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Neutral Citation Number: [2015] EWHC 1339 (QB) |
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Case No: HQ13X05199 |
IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
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Royal Courts of Justice Strand, London, WC2A 2LL |
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15 May 2015 |
B e f o r e :
HIS HONOUR JUDGE COLLENDER QC
(sitting as a Judge of the High Court)
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Between:
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Mrs. Julie Connolly
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Claimant
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- and -
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Croydon Health Services NHS Trust
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Defendant
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Mr Meredith-Hardy (instructed by Morrisons LLP) for the Claimant
Mr Barnes (instructed by Capsticks LLP) for the Defendant
Hearing dates: 10, 11, 12, 13, 16 March and 17 April 2015
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HTML VERSION OF JUDGMENT
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Crown Copyright ©
JUDGE COLLENDER QC
INTRODUCTION
- This is a claim for damages for personal injuries and consequential loss arising from the performance of a medical diagnostic procedure, an angiogram, upon the Claimant, Mrs Connolly, on 19 June 2009 at the Mayday University Hospital, in Croydon.
- The Defendant is the National Health Service Trust responsible for the medical and surgical services at the hospital. It is agreed that the Defendant is vicariously liable for the acts and omissions of its staff in the course of their NHS employment.
- Mrs Connolly asserts that before the procedure was carried out the staff of the hospital negligently failed properly to obtain her consent for its performance, that during the procedure, the staff failed to halt the procedure upon her requiring it to be stopped and that in consequence, its continued performance amounted to a battery.
- Breach of duty, causation, and quantum, are all in issue.
THE FACTS
- I will set out the facts that are not, or I consider, on the evidence before me, cannot sensibly be disputed.
- Mrs Connolly was born on 21 July 1956 so, at the time of the procedure, was 52 and is now 59.
- Mrs Connolly's medical history shows that she has for a long time suffered from a range of medical conditions including heart burn, indigestion, Myalgic Encephalomyelitis (ME), and irritable bowel syndrome. In the past she has had episodes of depression, has complained of panic attacks and has for long been anxious about her health. She has, in common with many, exhibited a dislike of medical procedures.
- On 14 April 2009, Mr Connolly complained to her GP of symptoms that were consistent with, or suggestive of, angina pectoris. As a consequence, she was referred to the hospital where she attended for investigation on 28 April 2009. Following that consultation, Dr Sreekumar Sulfi of the hospital staff wrote to her GP:
"- chest pain history - considered to be suggestive of angina
Occurred on exercise, relieved by rest ... Risk factors for heart disease- patient stop smoking started 1970 stopped 2000 smoked on average 20 per day no history of strokes ... Examination heart sounds normal Apex beat, JVP normal. Carotid pulse was a normal. The following heart murmurs were present: ESM Grade: 3 Respiratory system: normal. Investigations- ECG. Clinical diagnosis of possible angina. Patient referred for echocardiogram
Typical chest pain, ex smoker, systolic murmur at the base of the heart. Echo and ETT arranged as urgent."
- An echocardiogram was performed on Mrs Connolly on 25 May 2009, the results of which were normal. On 3 June 2009, Mrs Connolly performed an exercise test following which Dr Goulielmos of the hospital recommended that an angiogram be performed on Mrs Connolly.
- I should describe my understanding of certain terms material to this case. Angiography is a medical imaging technique used to visualise the inside of blood vessels done by injecting a radio-opaque contrast agent into the blood vessel via a catheter introduced into a patient's arterial system with the assistance of guide wires and imaging the vessels so injected using X-ray techniques. The film or image of the blood vessels is called an angiogram and that term is commonly used to encompass the whole procedure. Angioplasty is a procedure in which initially the same techniques are used as for the production of an angiogram but after insertion of a catheter into a patient's arterial system various other items may also be introduced into the arterial system via the catheter, namely guide balloons and stents. A balloon may be used to open a narrowed or blocked artery. Most modern angioplasty procedures also involve inserting a stent, i.e. a short wire-mesh tube, into the artery during the procedure. The stent is left in place permanently to allow blood to flow more freely.
- Dr Goulielmos provided Mrs Connolly with a consent form preparatory to performance of an angiogram on her. In addition, Mrs Connolly was sent an information sheet that explained the procedure in detail, and described risks involved with the procedure.
- In particular, the information sheet stated that:
"
As all blood vessels are connected to the heart, gently passing the catheters through the arteries and veins carries them painlessly into the heart
In skilled and experienced hands problems are uncommon. Nevertheless, there is a small risk that a badly narrowed artery will block during the test. This can cause a myocardial infarction (heart attack) which can have serious consequences. This is more a risk of the disease rather than the technique
"
- Mrs Connolly duly signed the consent form and, on 19 June 2009, attended the hospital for the procedure to be performed in what is called a catheter laboratory. The laboratory was equipped with an operating type bed or table, an X-ray machine, and equipment to monitor the patient's vital signs. Medical staff in the laboratory included the Dr Mechery, the operator, Mr Griffiths, a senior cardiac physiologist, who attended to monitor Mrs Connolly's vital signs from a glass screened off area to protect him from the X-rays, and Ms Shadbolt, a nurse.
- I will give a little more detail of the procedure. Under local anaesthetic, either via the radial or the femoral artery, the operator introduces a catheter into a patient's arterial system. The radial artery is smaller than the femoral artery. Different sizes of catheter can be used in these vessels. Relevant to this case are French catheters size 5 and 6. The catheter is passed up the artery to the aorta and the coronary artery into which an opaque contrast dye is injected to enable good views of the arteries and vessels of the heart. These can be viewed in real time by means of the X-ray machine.
- The timing and sequence of events in the course of Mrs Connolly's angiogram was not fully recorded as the equipment used does not automatically record what is visible during the procedure. However, the operator may record sequences of moving pictures of interest, in the course of the procedure and on a CD of Mrs Connolly's angiogram, 48 sequences of moving pictures showing the procedure at different times are recorded. I have viewed those sequences in the course of the trial.
- In Mrs Connolly's case the procedure commenced at about 11.00 a.m. when a local anaesthetic was given to Mrs Connolly and an incision was made in her right arm to permit access for a catheter via her radial artery. Soon after the insertion of the catheter Mrs Connolly began to suffer from spasm in her right arm and pain, so the catheter was withdrawn. Another attempt to perform the angiogram via the radial approach was unsuccessful and therefore some minutes later, Dr Mechery abandoned that approach and decided to attempt access via the femoral artery. Mrs Connolly was given a local anaesthetic in her leg and at about 11.30 a.m. a catheter was inserted via the femoral artery.
- During the procedure, Mr Griffiths monitored Mrs Connolly's blood pressure and ECG record. At the commencement of the procedure the ECG record was calibrated to zero at 10.55 a.m. and a baseline ECG was undertaken at 11.05 a.m. The ECG was continuously monitored by Mr Griffiths but it was not continuously recorded.
- The prescription record shows dispensation of 3 mg of morphine and 1.25 mg of diazepam at 11.20 a.m. It shows that between 11.20 a.m. and 11.50 a.m. a further 3 mg of morphine and 2.25 mg of diazepam was dispensed.
- In the course of the procedure Mrs Connolly's complained of pain in her right arm and of severe pain across her back, chest and jaw. It is agreed that she complained of pain in the right arm as soon as the spasm developed in her right arm; when she first complained of the other symptoms of pain is a central issue in this case.
- At an early stage in the course of the procedure Dr Mechery saw from images obtained of Mrs Connolly's heart that her left descending artery, known in the medical profession as the "LAD" was occluded. This is a serious and potentially life threatening condition as that artery serves about 40% of the muscle of the heart. The detection of that condition turned the procedure being performed on Mrs Connolly from an angiogram to an angioplasty.
- In Mrs Connolly's case the identified occlusion was cleared by insertion of a balloon and then two stents being inserted into the arterial system of Mrs Connolly's heart, the stents being employed at about 12.30 p.m. when it first became visible on X-ray that there had been a dissection of the left main stem artery. Whether that occurred shortly after the angiogram procedure was begun via the radial route or only after the femoral route was begun is another important issue in this action.
- At some time after Dr Mechery determined that the LAD was occluded he called for the attendance of Dr Beatt, the supervising cardiologist who probably arrived at or about the time when the femoral catheter was inserted.
- In consequence of the dissection, on 19 June 2009, Mrs Connolly was transferred to Kings' College Hospital. On 29 June 2009, at that hospital two further stents were inserted into Mrs Connolly's arterial system. She was discharged from King's College Hospital on 6 July 2009.
THE ISSUES IN THE CASE
- It is Mrs Connolly's case that, firstly, she did not provide a valid consent for the angiogram as she was provided with misleading information before the commencement of the angiogram. Secondly, it is her case that she withdrew such consent as she had given before access via the femoral route was undertaken and it was only after this time that she sustained a dissection of the LAD.
- The Defendant dispute that overall, misleading information was given to Mrs Connolly before she gave her consent to the performance of the angiogram. Even if it was, they deny that this vitiated her consent. They do not admit that her consent was withdrawn in the course of the procedure.
- The Defendant asserts that, at the material time, Mrs Connolly did not have capacity to withdraw consent and, therefore, any apparent withdrawal of consent was not valid. Mrs Connolly ripostes that at the time that she withdrew her consent she was fully conscious and aware of events such that she could withdraw her consent as, in particular, the medication that she had received would not have been sufficient to have affected her capacity. The Defendant also asserts that an event that threatened Mrs Connolly's life occurred before withdrawal of her consent such that the staff of the hospital were entitled to ignore any suggestion from her that she wished them to halt the procedure.
- Relevant to the issue of liability, rulings are sought from the court on the following questions.
(i) Before she gave her consent for the angiogram procedure, was Mrs Connolly provided with sufficient and accurate information so that her consent was effective, or was it vitiated by inadequate or misleading information?
(ii) When did dissection of the LAD occur in particular, was it before or after the femoral approach was undertaken?
(iii) When in the sequence of events did Mrs Connolly suffer from the pain from which she complained in her right arm, chest, neck and back, which she described as excruciating?
(iv) Did Mrs Connolly withdraw her consent to the continuance of the procedure before access was attempted via the femoral route?
(v) Did Mrs Connolly lack capacity to withdraw her consent due to the effects of medication given to her and if so, what is the legal effect of that circumstance?
(vi) Did an event that threatened Mrs Connolly's life occur before any withdrawal of her consent, and if it did, what was the legal effect of that happening?
(vii) On the premise that Mrs Connolly was given insufficient or misleading information before she consented to performance of the procedure, would she have refused an angiogram had she not been given that insufficient or misleading information?
(viii) On the premise that Mrs Connolly withdrew her consent to the continuance of the angiogram procedure after the radial approach was abandoned, would Mrs Connolly have consented to the continuation of the procedure had she been asked?
(ix) Had the hospital staff halted the procedure when consent was withdrawn, would the outcome have been any different?
THE LAW
- The test to be applied in respect of breach of duty in respect of clinical negligence is well known. It was set out in a jury direction by McNair J in Bolam v Friern Hospital Management Committee [1957] 1 WLR 583 as follows:
"I myself would prefer to put it this way, that [a medical practitioner] is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art. ... Putting it the other way round, a man is not negligent, if he is acting in accordance with such a practice, merely because there is a body of opinion who would take a contrary view."
- In his speech in Bolitho v City and Hackney Health Authority [1998] A C 232 Lord Browne-Wilkinson commented on the Bolam test as follows at 241F-242B:
"in my view, the court is not bound to hold that a defendant doctor escapes liability for negligent treatment or diagnosis just because he leads evidence from a number of medical experts who are genuinely of opinion that the defendant's treatment or diagnosis accorded with sound medical practice. In the Bolam case itself, McNair J. stated [1957] 1 W.L.R. 583, 587, that the defendant had to have acted in accordance with the practice accepted as proper by a "responsible body of medical men." Later, at p. 588, he referred to "a standard of practice recognised as proper by a competent reasonable body of opinion." Again, in the passage which I have cited from Maynard's case, Lord Scarman refers to a "respectable" body of professional opinion. The use of these adjectives -responsible, reasonable and respectable--all show 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 their minds to the question of comparative risks and benefits and have reached a defensible conclusion on the matter."
- At 243 A-D after reference to authorities, he said:
"These decisions demonstrate that in cases of diagnosis and treatment there are cases where, despite a body of professional opinion sanctioning the defendant's conduct, the defendant can properly be held liable for negligence (I am not here considering questions of disclosure of risk). In my judgment that is because, in some cases, it cannot be demonstrated to the judge's satisfaction that the body of opinion relied upon is reasonable or responsible. In the vast majority of cases the fact that distinguished experts in the field are of a particular opinion will demonstrate the reasonableness of that opinion. In particular, where there are questions of assessment of the relative risks and benefits of adopting a particular medical practice, a reasonable view necessarily presupposes that the relative risks and benefits have been weighed by the experts in forming their opinions. But if, in a rare case, it can be demonstrated that the professional opinion is not capable of withstanding logical analysis, the judge is entitled to hold that the body of opinion is not reasonable or responsible.
I emphasise that in my view it will very seldom be right for a judge to reach the conclusion that views genuinely held by a competent medical expert are unreasonable. The assessment of medical risks and benefits is a matter of clinical judgment which a judge would not normally be able to make without expert evidence. As the quotation from Lord Scarman makes clear, it would be wrong to allow such assessment to deteriorate into seeking to persuade the judge to prefer one of two views both of which are capable of being logically supported. It is only where a judge can be satisfied that the body of expert opinion cannot be logically supported at all that such opinion will not provide the bench mark by reference to which the defendant's conduct falls to be assessed."
- A patient is entitled to the provision of sufficient information to permit an informed choice as to whether to consent to a procedure. A failure to have provided sufficient information gives rise to a cause of action in negligence. In Sidaway v Board of Governors of the Bethlehem Royal Hospital [1985] 1 AC 871, Lord Bridge said at 900:
"
a decision what degree of disclosure of risks is best calculated to assist a particular patient to make a rational choice as to whether or not to undergo a particular treatment must primarily be a matter of clinical judgment. It would follow from this that the issue whether non-disclosure in a particular case should be condemned as a breach of the doctor's duty of care is an issue to be decided primarily on the basis of expert medical evidence, applying the Bolam test
But I do not see that this approach involves the necessity "to hand over to the medical profession the entire question of the scope of the duty of disclosure, including the question whether there has been a breach of that duty." Of course, if there is a conflict of evidence as to whether a responsible body of medical opinion approves of non-disclosure in a particular case, the judge will have to resolve that conflict. But even in a case where, as here, no expert witness in the relevant medical field condemns the non-disclosure as being in conflict with accepted and responsible medical practice, I am of opinion that the judge might in certain circumstances come to the conclusion that disclosure of a particular risk was so obviously necessary to an informed choice on the part of the patient that no reasonably prudent medical man would fail to make it. The kind of case I have in mind would be an operation involving a substantial risk of grave adverse consequences, as, for example, the ten per cent. risk of a stroke from the operation which was the subject of the Canadian case of Reibl v. Hughes, 114 D.L.R. (3d) 1. In such a case, in the absence of some cogent clinical reason why the patient should not be informed, a doctor, recognising and respecting his patient's right of decision, could hardly fail to appreciate the necessity for an appropriate warning."
- Implicit within the scope of the duty to provide sufficient information to permit a patient to make a proper informed choice is the obligation to provide accurate information. The giving of inaccurate or misleading information to a patient may vitiate their consent and amount to negligence that gives rise to a cause of action if causation of damage is established. However, English law has avoided adopting the American doctrine of informed consent. (See Lord Diplock in Sidaway [Supra] at 894.)
- In In Re T (Adult: Refusal of Treatment) [1993] Fam 95 Lord Donaldson said at 114:
"
On the other hand, misinforming a patient, whether or not innocently, and the withholding of information which is expressly or impliedly sought by the patient may well vitiate either a consent or a refusal
"
- When providing information, a reasonable effort should be made to communicate the information to the patient so that the patient can understand what is being stated. In Smith v Tunbridge Wells Health Authority [1994] 5 Med LR 334 QBD at 339 Morland J said:
"When recommending a particular type of surgery or treatment, the doctor, when warning of the risk, must take reasonable care to ensure that his explanation of the risk is intelligible to his particular patient. The doctor should use language, simple but not misleading, which the doctor perceives from what knowledge and acquaintanceship that he may have of the patient (which may be slight), will be understood by the patient so that the patient can make an informed decision as to whether or not to consent to the recommended surgery or treatment"
- NHS guidance on consent is set out in a "Reference Guide to Consent for Examination or Treatment". At 5 and 6 it states:
"4. To give valid consent the patient needs to understand in broad terms the nature and purpose of the procedure. Any misrepresentation of these elements will invalidate consent
5.3 In considering what information to provide, the health profession should try to ensure that the patient is able to make a balanced judgment on whether to give or withhold consent"
- An important recent decision upon the nature of the duty of care owed by members of the medical profession to patients in relation to advice and information given to patients before their consent is sought to the performance of an operation is the unanimous decision of the Supreme Court in Montgomery v Lanarkshire Health Board [2015] UKSC 11.
- The judgment of the Court was given by Lords Kerr and Reed with which the five other Justices sitting on the appeal agreed. In the judgment the decision of the Court of Appeal in Pearce v United Bristol Healthcare NHS Trust [1999] PIQR P53 and the dissenting opinion of Lord Scarman in Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [Supra] were approved.
- The Court said at para. 86:
"... because the extent to which a doctor may be inclined to discuss risks with a patient is not determined by medical learning or experience, the application of the Bolam test to this question is liable to result in the sanctioning of differences in practice which are attributable not to divergent schools of thought in medical science, but merely to divergent attitudes among doctors as to the degree of respect owed to their patients."
- The principles to be followed in determining the duty of care to be applied in considering whether or not a medical practitioner has fulfilled their duty of care when informing a patient in respect of a medical procedure or operation to be performed on that patient so that they can decide whether or not to consent to that procedure or operation were summarised at para. 87 as follows:
"An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken. The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient's position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it."
- The Court noted the need to consider the full facts and circumstances of the individual patient in each case, stating at para. 89:
"... the assessment of whether a risk is material cannot be reduced to percentages. The significance of a given risk is likely to reflect a variety of factors besides its magnitude: for example, the nature of the risk, the effect which its occurrence would have upon the life of the patient, the importance to the patient of the benefits sought to be achieved by the treatment, the alternatives available, and the risks involved in those alternatives. The assessment is therefore fact-sensitive, and sensitive also to the characteristics of the patient."
- A patient has the right not to consent to a medical procedure or to withdraw consent should it have been given. In Sidaway v Board of Gov of Bethlem Royal Hospital & Maudsley Hospital [Supra] Lord Templeman said at 903:
"
If the doctor making a balanced judgment advises the patient to submit to the operation, the patient is entitled to reject that advice for reasons which are rational, or irrational, or for no reason
"
- Similarly, in Airedale NHS Trust v Bland [1993] AC 789 Lord Mustill said at 891:
"
If the patient is capable of making a decision on whether to permit treatment and decides not to permit it his choice must be obeyed, even if on any objective view it is contrary to his best interests. A doctor has no right to proceed in the face of objection, even if it is plain to all, including the patient, that adverse consequences and even death will or may ensue
"
- NHS guidance on the withdrawal of consent is set out in the Reference Guide already referred to at 10:
"Withdrawal of consent
18. A patient with capacity is entitled to withdraw consent at any time, including during the performance of a procedure. Where a patient does object during treatment, it is good practice for the practitioner, if at all possible, to stop the procedure, establish the patient's concerns, and explain the consequences of not completing the procedure. At times an apparent objection may reflect a cry of pain rather than withdrawal of consent, and appropriate reassurance may enable the practitioner to continue with the patient's consent
"
- If a patient has capacity to refuse treatment a doctor has no lawful entitlement to treat the patient even if the doctor considers that the treatment is reasonable or necessary to save life. In the absence of consent there is a battery. See In Re T (Adult: Refusal of Treatment) [Supra] Fam. 95 at 102 per Lord Donaldson:
"The law requires that an adult patient who is mentally and physically capable of exercising a choice must consent if medical treatment of him is to be lawful, although the consent need not be in writing and may sometimes be inferred from the patient's conduct in the context of the surrounding circumstances. Treating him without his consent or despite a refusal of consent will constitute the civil wrong of trespass to the person and may constitute a crime. If, however, the patient has made no choice and, when the need for treatment arises, is in no position to make one - for example, the classic emergency situation with an unconscious patient - the practitioner can lawfully treat the patient in accordance with his clinical judgment of what is in the patient's best interest.."
- At 112 in the same authority, Lord Donaldson said:
"Society's interest is in upholding the concept that all human life is sacred and that it should be preserved if at all possible. It is well established that in the ultimate the right of the individual is paramount. But this merely shifts the problem where the conflict occurs and calls for very careful examination of whether, and if so the way in which, the individual is exercising that right. In case of doubt that doubt falls to be resolved in favour of the preservation of life, for if the individual is to override the public interest he must do so in clear terms."
- The issue of the withdrawal of consent was considered in the Court of Appeal of Ontario in Ciarlariello v Schacter [1993] 2 SCR 119 where it was stated at paras. 20 to 22:
"Whether or not there has been a withdrawal of consent will always be a question of fact. The words used by a patient may be ambiguous. Even if they are apparently clear, the circumstances under which they were spoken may render them ambiguous. On some occasions, the doctors conducting the process may reasonably take the words spoken by the patient to be an expression of pain rather than a withdrawal of consent. Obviously, these are questions of fact which will have to be resolved by the trial judge.
While the doctor's interpretation of the patient's cries in Mitchell v McDonald may have been reasonable in that case, generally if there is any question as to whether the patient is attempting to withdraw consent, it will be incumbent upon the doctor to ascertain whether the consent has in fact been withdrawn. It should not be forgotten that every patient has a right to bodily integrity. This encompasses the right to determine what medical procedures will be accepted and the extent to which they will be accepted. Everyone has the right to decide what is to be done to one's own body. This includes the right to be free from medical treatment to which the individual does not consent. This concept of individual autonomy is fundamental to the common law and is the basis for the requirement that disclosure be made to a patient. If, during the course of a medical procedure a patient withdraws the consent to that procedure, then the doctors must halt the process. This duty to stop does no more than recognize every individual's basic right to make decisions concerning his or her own body
An individual's right to determine what medical procedures will be accepted must include the right to stop a procedure. It is not beyond the realm of possibility that the patient is better able to gauge the level of pain or discomfort that can be accepted or that the patients premonitions of tragedy or mortality may have a basis in reality. In any event, the patient's right to bodily integrity provides the basis for the withdrawal of a consent to a medical procedure even while it is underway. Thus, if it is found that the consent is effectively withdrawn during the course of the proceeding then it must be terminated. This must be the result except in those circumstances where the medical evidence suggests that to terminate the process would be either life threatening or pose immediate and serious problems to the health of the patient.
The issue as to whether or not a consent has been withdrawn during the course of a procedure may require the trial judge to make difficult findings of fact. If sedatives or other medication were administered to the patient then it must be determined if the patient was so sedated or so affected by the medication that consent to the procedure could not effectively have been withdrawn. The question whether a patient is capable of withdrawing consent will depend on the circumstances of each case. Expert medical evidence will undoubtedly be relevant, but it will not necessarily be determinative of the issue. Indeed, in cases such as this where the patient must be conscious and cooperative in order for the procedure to be performed, it may well be beyond doubt that the patient was capable of withdrawing consent".
- These and other authorities, deal with two particular questions that may confront a medical practitioner in dealing with the question of the validity or otherwise of a patient's withdrawal of their consent to a medical procedure. These questions are, had the patient capacity at the material time to withdraw consent and the extent to which, if at all a medical emergency confronting a medical practitioner may entitle them to continue with a procedure in the face of objection from a patient.
- In Border v Lewisham & Greenwich NHS Trust 21.1.15 [2015] EWCA Civ 8, where Richards LJ stated at para. 21:
"
In a medical emergency, when the patient is incapable of giving consent, a doctor may proceed without consent provided that he or she is acting in the patient's best interests (see, for example, St George's Healthcare NHS Trust v S [1999] Fam 26 at 45B). The judge may have had that principle in mind. On the evidence, however, this was not such a case of medical emergency. The claimant was in the emergency room the resuscitation room but she was fully conscious and capable of giving or withholding her consent. The judge was therefore wrong to regard the issue of consent as unimportant".
- In MB (Caesarean Section) [1997] 2FLR 426, the Court of Appeal noted that an individual's capacity to make particular decisions may fluctuate or be temporarily affected by factors such as pain, fear, confusion or the effects of medication and the assessment of the capacity of a patient validly to withdraw consent must be time and decision specific.
- The question of necessity, was discussed by the House of Lords in Re F (Mental Patient: Sterilisation) [1990] 2 AC 1. The scope of the doctrine was stated by Lord Goff of Chieveley, at page 75 as follows:
"...to fall within the principle, not only (1) must there be a necessity to act when it is not practicable to communicate with the assisted person, but also (2) the action taken must be such as a reasonable person would in all the circumstances take, acting in the best interests of the assisted person."
- Lord Donaldson (in the Court of Appeal) said in the same authority at page 17:
"In an emergency a doctor has little time to ponder the choices available. He must act in the best interests of his patient, as he sees them, but he can be more readily forgiven if he errs in his judgment."
- What a patient would have done if a procedure is temporarily halted by a medical practitioner further to explore an apparent withdrawal of consent must be answered in part on an objective analysis (see Smith v Barking Havering and Brentwood NHS Trust [1994] 5 Med LR 285).
THE EVIDENCE
- I turn now to the evidence. I heard from Mrs Connolly and her husband. For the Defendant I heard from Dr Goulielmos, Nurse Shadbolt, Mr Griffiths and Dr Mechery. I heard expert medical evidence for the Claimant, from Dr Perry, and for the Defendant from Dr Freeman, both consultant cardiologists. For Mrs Connolly I received in evidence written reports, of Dr Steadman, a psychiatrist and ENT evidence from Dr McCombe. I received a character reference from Mrs Connolly's pastor, at the Christ Central Church, that speaks in warm terms of Mrs Connolly and, in particular, notes that she is one of the "most honest and real people" that he knows.
- Mrs Connolly told me that she has a clear recollection of what she was told by Dr Goulielmos as set out in her witness statement dated 2 April 2014. In particular, he told her that the angiogram procedure was a
"brilliant and safe test
that there is only a risk to someone with diseased arteries."
Her evidence was that from this she understood that there was no risk to her as she knew that her arteries were healthy; had she been told there was a risk that healthy arteries could be damaged by the performance of an angiogram, she would not have proceeded with the procedure. It was only because of the advice that she received to have the angiogram, and that the procedure was safe if she did not have diseased arteries, that she decided to go ahead with the procedure.
- She told me she read the information leaflet given to her. She said in the course of her evidence:
"I just thought I will go because that is what they want me to do. I did not realise what a major operation this was. I was being persuaded by my husband."
- She said in her statement that after the procedure began she felt an extremely severe pain in her right arm of which she complained to the medical staff. She said that she heard the doctor, Dr Mechery, say, "is she 32 or 52?" and she said, "I'm 52, ..why does this matter?" to which Dr Mechery replied that younger women usually go into spasm if it is put in the arm. He then said, "We'll go in her leg instead" to which Mrs Connolly said "I don't want you to" to which Dr Mechery answered, "It won't take long as we've put it in your leg now." Mrs Connolly said that she was confused and afraid and that she had lost confidence in the ability of the staff to carry out the procedure painlessly and repeatedly said, "I need this to stop now."
- Dr Mechery said, "I've seen one side and the artery's clear and looks good, I just need to get round the other side. It shouldn't take a minute." Mrs Connolly said, "I don't want you to, I need this to stop now.
I then experienced the most excruciating pain of my life across my back and my chest and my jaw." She said in her evidence before me that in the course of the procedure he was calm, reassuring, sought to put her at her ease and seemed "fine in his attitude."
- Mrs Connolly's case was that Dr Mechery should have abandoned the procedure after she complained of pain in her right arm that was consistent with spasm. She told him at that stage that she wanted it to stop and if he had done so she would not subsequently have agreed to it being continued, whatever the doctor had said to her, and the dissection would not therefore have occurred. She withdrew her consent for the procedure to continue before access was attempted via the femoral route and that she did not complain of "excruciating" pain until after access to her arterial system had been gained by the femoral route.
- Mrs Connolly was cross-examined about a number of matters. She said she did not know if she would have agreed to the procedure continuing if she had been told that an artery in her heart was blocked and there was a significant danger to her heart; she said she may have agreed.
- She was asked about a passage in an addendum report of Dr Perry dated 4 June 2013. Amongst the documents listed by Dr Perry at the beginning of that report were the following documents:
6. A detailed statement from Mrs Connolly
7. Medical notes from a telephone consultation on 14.02.2013 with Mrs Connolly
- The material passage was:
"she [Mrs Connolly] stated that she was particularly uncomfortable during the procedure and asked on at least two occasions that the procedure be stopped and felt that she had withdrawn her consent. She was unaware of a different arterial approach via the femoral artery."
- The observation in the last sentence of that quotation was clearly inconsistent with what Mrs Connolly said in her statement of 2 April 2014. Initially, Mrs Connolly accepted in cross-examination that Dr Perry had correctly recorded the position. She was asked, "You were unaware on the day of the procedure of the approach via femoral artery?" To which question she replied "I think so." Dr Perry accepted in cross-examination that this was the correct reading of his noted record.
- Later in her evidence Mrs Connolly retreated from this position. She asserted that the pain she suffered, apart from the pain in her right arm, occurred after the femoral approach was adopted. She said that she was not overly sedated.
- In the course of final submissions an attempt was made on Mrs Connolly's behalf to put in evidence part, or parts, of a previous statement made by her. It was clear that the application was made to rebut the suggestion that Mrs Connolly had told Dr Perry that at the time of the procedure she was unaware of a different arterial approach being made via the femoral artery. I have not seen that statement and nothing was said when the attempt to use it was made about when the statement was made or whether it was signed. The statement was not shown to the Defence before or during the application and it was made clear on behalf of Mrs Connolly that only part or parts of the statement would be put in evidence. Objection was taken by the Defence to the admission of the statement on that basis.
- The court indicated in the course of the application that, in line with the authority of Great Atlantic Insurance Company v Home Insurance Company Ltd [1981] 1 WLR 529, the court would not countenance privilege being waived as to only part, or parts, of the statement and after a short adjournment for Mrs Connolly and Counsel to consider the position, the application was not further pursued.
- The parties' final submissions were completed on 17 March 2015. On 26 March 2015 Mrs Connolly lodged an application for an order:
"That the Claimant be given permission to re-open her case prior to judgment to address one issue and this is to rebut the allegation that C only became aware after Dr Perry's telephone conversation on 14.2.13 that access had been gained via the femoral route."
- The application was supported by a witness statement from Mrs Connolly's solicitor, a copy of a witness statement of Mrs Connolly dated 14.02.13, Dr Perry's notes of the consultation on 14.03.13, and an email from Dr Perry dated 26.03.15, addressing the meaning of his notes.
- The court was asked to deal with the application at a telephone hearing with a time estimate of 30 minutes and a draft order was attached to the application. I required the parties to attend court for a conventional oral hearing of the application at which I heard full submissions of the parties on the application. At the conclusion of that hearing the position was reached that the parties agreed that I would consider the material submitted in support of the application de bene esse and would include my conclusions upon the significance of the material in my judgment.
- I will not set out the detail of that material in this judgment. In summary, the evidence supported the contention of Mrs Connolly that before Dr Perry's telephone call of 14.02.13 Mrs Connolly was aware that in the course of the angiogram, arterial access had been gained via the femoral route. The history given meant that the Defendant had no opportunity to cross-examine Mrs Connolly and Dr Perry upon the evidence placed before the court by means of the application dated 26 March 2015.
- Mrs Connolly confirmed the evidence in her witness statement as to the effects of the incident on her health and life and her claim for damages. She was asked about a letter from her GP, Dr Byrne, dated 24 September 2009, i.e. three months after the procedure, and in particular the last sentence of a passage in which the doctor reported:
"since discharge she has had significant problems with her combination of dual anti-platelet therapy with stomach cramps and a variety of symptom. Although this was eased to some degree by Ranitidine, the Ranitidine itself also caused other problems. She also complains of some neck tightness when she is stressed but has no problems with exercise and can run and walk the dog without limitation."
She said in giving this evidence the doctor had, "got the wrong end of the stick."
- She was asked about a note from the outpatient cardiac clinic dated 15.10.2009 that read;
"We saw Mrs Connolly to offer psychological support and cardiac rehabilitation following this event. She declined referral to the cardiac rehabilitation and education programme and has indicated that she no longer feels that she would benefit from continued contact with us."
Mrs Connolly said that she did not want to continue to go to the clinic because the clinic did not understand how to treat her and were not helping her at all.
- She accepted in cross-examination that she had produced no figures to support her husband's loss of earning claim earnings and nothing to demonstrate the amount of her own earnings before 2009.
- I heard from Mr Connolly. He confirmed before me his witness statement dated 27 March 2014 that gave confirmatory evidence of Mrs Connolly's account of what happened. Much of his evidence was hearsay. His statement was given many years after the events described.
- For the Defendant I heard firstly from Dr Goulielmos. He detailed to me his standard practice for consent, which he adopts with 300 patients per year. He commented in his evidence upon Mrs Connolly's evidence about what she said she was told by him about the risks of the angiogram procedure. He told me that these are not the type of comments that he would have made. He said that he would have told her that there was a need to investigate by angiogram because there was evidence that there was something wrong with her heart. He would have given Mrs Connolly the opportunity to ask questions. He would not have told her that her arteries were normal.
- Ms Shadbolt's evidence was that she had no specific recollection of the angiogram procedure performed on Mrs Connolly. Her evidence was that if anything unusual happened in the course of a procedure she would know and hear about it because the catheter laboratory was quite small; she had never seen a doctor ignore a patient's request to stop a procedure. She would have been about a metre away from Dr Mechery during the procedure.
- Mr Griffiths also had no specific recollection of the angiogram procedure performed on Mrs Connolly. He told me that the log of events he compiled was (perforce) not complete because of his other duties in the course of such a procedure. In the course of a procedure he is located behind a glass screen. He is able to see everything that happens but not always hear everything being said. He noted that he has to be very focused on the various monitors to ensure that the patient remains haemodynamically stable. Mr Griffiths says he cannot recall Mrs Connolly having asked for the angiogram procedure to stop.
- The evidence of Dr Mechery was of central importance in the case. He described in his written statement of 21 March 2014 how he had reviewed the relevant medical notes on Mrs Connolly and gave his recollection of the procedure carried out on her. It is material to relate his evidence to the event log, and the clinical and prescription records kept in the course of this procedure.
- At 11.03 a.m. a vasodilator drug having been administered, a catheter was inserted into the Claimant's right radial artery. Dr Mechery said he managed this, quickly and without difficulty. Thereafter, he made several injections of contrast dye into Mrs Connolly's arterial system between 11.06 a.m. and 11.08 a.m. These injections revealed the left main and circumflex arteries, but the left anterior descending artery (LAD) could not be visualised because it was occluded. As he could not see evidence of dissection, Dr Mechery suspected that the artery had gone into spasm. He knew it was of the utmost importance that the LAD was opened to prevent permanent disabling damage to the myocardium or even death.
- Dr Mechery says he removed the catheter with difficulty because of spasm in the right arm. At 11.10 a.m. he attempted to insert a right sided catheter but could not do so because the radial artery was still in spasm. A drug was administered to try and resolve the spasm and the last entry in the event log detailing the attempt to gain access by the radial artery is at 11.23 a.m.
- As already noted, at 11.20 a.m. a number of drugs were written up in the prescription record, including diazepam and morphine. A clinical record timed at 11.30 a.m. notes:
"c/o [complaining of] chest discomfort, neck pain & back pain
I/V diazemuls, morphine given in divided doses & GTN spray S/L also given
ECG changes noted
Dr Beatt in proceeded"
- This entry is consistent with the drugs prescribed at 11.20 a.m. being administered in response to what Mrs Connolly described as the excruciating pain that developed across her back, chest, and jaw, after Dr Mechery said, "I just need to get round the other side." As already noted above, the point at which Dr Mechery attempted to use a right sided catheter was at 11.10 a.m.
- Dr Mechery described the situation in his witness statement as follows:
"I had not yet seen the right coronary artery ("RCA"), and I was conscious that we did not know what condition the RCA was in. With the LAD blocked I needed to urgently get access to the coronary arteries."
- Considering its importance, I will set out a substantial passage from Dr Mechery written statement evidence that deals with the question of Mrs Connolly's consent to what followed.
"I do not recall Mrs Connolly requesting the procedure to stop at this point. However, the procedure had now turned into a medical emergency and I was not concentrating on conversations with Mrs Connolly, but rather was concentrating on saving her life and ensuring that all necessary analgesics and sedatives were provided to make her as comfortable as possible in the circumstance. It is possible that Mrs Connolly asked for the procedure to stop due to the pain of predominantly the blocked coronary artery, and also secondarily due to the radial spasms. If Mrs Connolly had asked for the procedure to stop it would not have been possible to do so at this stage without catastrophic and life threatening consequences. I do not recall feeling at any point that Mrs Connolly was "withdrawing consent" and I would certainly recall if this was the case. I do not undertake any invasive procedure without consent unless it is a lifesaving emergency situation. In this case, Mrs Connolly was in a critical situation very soon after the start of the procedure and needed rapid emergency treatment. In this situation it is my job, and the job of the nurses, to try and relieve the patient of any pain and reassure them. I note that intravenous diazepam, midazolam and morphine were administered to Mrs Connolly to provide pain relief and to give sedation. We had a low threshold to give sedative and opiate analgesics intravenously for pain in the catheterisation lab in 2009. We would give as much analgesia as needed and the dose may vary between individuals. Mrs Connolly received multiple doses of diazepam, midazolam and morphine. My angiogram report says a total of 13mg morphine and 6mg of diazepam was administered soon after Mrs Connolly experienced pain. As these are given intravenously, their effect is almost instantaneous. It is standard practice for the nurses to be talking to the patient throughout the angiogram procedure and explain what is happening, as the operator is under great pressure and needs to make very important decisions quickly. However, explaining what is happening to a patient who is in pain and under the influence of the above mentioned drugs is very difficult. I note that that Mrs Connolly says that she believes she may have lost consciousness and she states that her recollection of events is patchy. The diazepam and morphine could have caused her to have a period of no recollection/ 13mg of morphine is a high dose for patient not accustomed to taking morphine and 6mg of diazepam is enough to make a person of low body weight such as Mrs Connolly very sleepy."
- In his oral evidence to me, Dr Mechery said that although everything happened very quickly he very clearly remembers the sequence of events. When he saw that Mrs Connolly had a blocked LAD he knew that there were various possible causes, spasm, dissection or thrombosis. Pain for the patient would follow within seconds or minutes. The situation he faced was catastrophic. He thought that the drugs prescribed between 11.20 a.m. and 11.50 a.m. were most likely given one after another. It was likely that he asked for the morphine to be given first and that it would have been given successively in small doses. He called the consultant on duty. He decided to attempt to gain access via the femoral artery. There is an entry in the event log at 11.23 a.m., "femoral approach attempted." At 11.31 a.m. a catheter was inserted, and Dr Mechery noted that by this stage Dr Beatt, the consultant, for whom Dr Mechery had sent, had arrived.
- It was put to Dr Mechery that a Cardiac Catheterisation Report that he prepared on 19 June 2009 that noted: "pain back and neck after the angiogram with JL4 6F" evidences the fact that Mrs Connolly only suffered the described pain as opposed to only pain in the right arm from spasm in that arm, after the femoral approach was undertaken. The use of a 6 French catheter was only consistent with the femoral route, not the radial route for which a J5 catheter should have been used.
- Dr Mechery did not accept that analysis. He told me that the two catheters J5 and J6 were interchangeable and that there was no particular significance in the fact that he had written down J6 rather than J5. He said he might well have used a J5 catheter although he wrote down J6. He told me that a proper reading of the Catheterisation report shows that it was chronologically set out. So reading the report demonstrates that the pain there recorded was experienced by Mrs Connolly early in the procedure in the course of the radial, not the femoral entry of the catheter.
- I turn to the evidence of the cardiologists. I should say this at the outset of my review of the evidence of these experts. Inevitably, in my conclusions I have had to decide on certain matters between the differing views of the cardiologists. However, I must say that my task has not been made easier by the fact that I found the evidence of both Dr Perry and Dr Freeman generally to be authoritative, clear, open and helpful.
- Dr Perry considered that the information sheet was:
"misleading as it implied that coronary dissection or major complications did not happen in patients who had normal coronary arteries."
However, the experts considered this issue and concluded in their Joint Statement in answer to the question:
"Was there a breach of Duty with regarding to [sic] informed consent-
Both experts agree that there was no Breach of Duty in respect of obtaining informed consent prior to undertaking the angiogram. In particular they agree that there was no duty to inform of specific risks of dissection or spasm whether the artery was stenosed on in an otherwise healthy artery. Both experts also agree that there was no Breach of Duty in respect of the information sheet provided. If the Court finds that 'the Claimant was informed orally that the risk of stroke and heart attack was only present if she had arteries that were not healthy' - both experts agree this to be misleading and inaccurate if stated, but not Breach of Duty."
- There was considerable further common ground between the experts. They agreed that:
(i) the LAD was occluded at the time of the first angiographic injection at 11.06 a.m. at which time there were no ECG changes;
(ii) there were no further ECG's taken until 11.33 a.m. at which time the ECG showed ST elevation and that Mrs Connolly's blood pressure was 125/63 and that at 11.48 a.m. her blood pressure was 105/58. The first noted time was the point at which Mrs Connolly's condition became life threatening - at the second she became haemodynamically unstable;
(iii) whilst it is possible the LAD was occluded before the angiogram procedure was carried out due to underlying coronary disease, it was most likely that the LAD was occluded due to instrumentation of the left main stem at 11.06 a.m.;
(iv) the LAD was still occluded at the next repeat coronary injection despite anti-spasm medication having been administered;
(v) radial artery spasm was present at 11.17 a.m. Both experts agree that the cause was catheterisation and that such is an acknowledged risk of the use of the radial route for an angiogram;
(vi) at 11.20 a.m. the drug sheet shows that Mrs Connolly was prescribed 1.25mg diazemuls and 3mg morphine to alleviate symptoms;
(vii) the correct further treatment was for the administration to the patient of sedation and nitrates, (the patient already having been administered some vasodilator drugs at the start of the procedure), withdrawing the catheter and changing the arterial access route either to the left radial or femoral to assess the state of the LAD.
- A fundamental issue upon which the cardiologists disagree is as to when the dissection occurred. Dr Perry's considered that whilst the LAD appeared occluded from its first visualisation, symptoms suffered by Mrs Connolly before access was sought via the femoral route were consistent with spasm alone being responsible for that occlusion.
- Dr Freeman considered the evidence did not demonstrate that the dissection occurred following access to Mrs Connolly's arterial system via the femoral route. Her opinion was that Mrs Connolly sustained the rare complication of dissection of the left main stem at the time of initial intubation with the coronary catheter at 11.06 a.m. although it was not then visualised. The short interval of time before Mrs Connolly suffered from excruciating pain matched the development of myocardial ischaemia due to interruption of her coronary blood flow.
- Dr Freeman considered it to be very rare for spasm to persist for such a prolonged period as contemplated by Dr Perry and for the LAD to be in spasm with the other arteries still functioning normally and that the circumstances in Mrs Connolly's case of the occlusion of her LAD were atypical for spasm.
- Dr Freeman's gave as her opinion that Mrs Connolly had "temporal incapacity" before 11.31 a.m. by reason of the drugs administered to her by that time. In contrast, Dr Perry did not consider that 3 mg of morphine and 1.25 mg of diazepam would have rendered Mrs Connolly "incapable of withdrawing her consent".
- In the course of cross-examination Dr Perry accepted the following:
(i) That it is rare to encounter arterial spasm that causes a complete occlusion;
(ii) That spasm is more common on the right (65%) than on the left (35%);
(iii) Less than 10% of cases of spasm persist for the length of time postulated by Dr Perry in Mrs Connolly's case;
(iv) That upon occlusion pain would be expected to start more or less straight away;
(v) That it was highly likely that Mrs Connolly's excruciating pain started after 11.10 a.m. and before 11.25 a.m.
(vi) That it would have been sensible to prescribe the analgesic drugs prescribed and apparently administered between 11.20 a.m. and 11.50 a.m. for the chest pain complained of by Mrs Connolly and that it would have been reasonable to give the morphine prescribed in a series of doses at 5 minute intervals;
(vii) That the drugs prescribed for Mrs Connolly would have had a minor impact on her capacity;
(viii) That it would have been consistent but unusual to prescribe morphine for pain consequent upon radial artery spasm alone;
(ix) If the LAD becomes occluded there is a risk to a patient of serious damage and death within minutes;
(x) It would be a reasonable view in Mrs Connolly's case to suggest that the dissection occurred from the outset of the performance of the angiogram;
(xi) He would not criticise the decision to initiate the femoral approach after spasm was encountered in the radial artery;
(xii) That the period of recovery for Mrs Connolly after the procedure and the consequent treatment was about two months.
- In the course of cross-examination Dr Freeman accepted the following:
(i) She would expect an operator to call the consultant very quickly once an occluded LAD was detected;
(ii) That an edge dissection, which Dr Mechery considered to be the type suffered by Mrs Connolly, is often related to the insertion of a stent or stents;
(iii) There was no difference in the angiogram images at the dissection site between 11.06 a.m. and 11.33 a.m.;
(iv) An operator might give morphine for severe radial spasm pain.
- That concludes my review of the evidence in this case. I turn to my conclusions.
CONCLUSIONS
- I will take the questions upon which I am asked to rule in the order set out above; some can conveniently be taken together. Some of my conclusions, especially on the first question have relevance in relation to my conclusions on other questions. The first question is,
(i) Was Mrs Connolly provided with sufficient and accurate information so that her consent given for the angiogram procedure to be carried out was effective, or was it vitiated by inadequate or misleading information?
- This question is two in one. Was all or any of the information given to Mrs Connolly before she gave her consent to the procedure misleading and inaccurate, and if it was did that result in her not properly giving consent for the procedure?
- There were two possible sources for the assertion that Mrs Connolly was misinformed, her conversation with Dr Goulielmos, and the information sheet.
- As already noted, I heard evidence from both Mrs Connolly and Dr Goulielmos on their conversation. I was generally impressed by Dr Goulielmos's evidence and his account of that conversation. I find it hard to accept that he departed from his usual practice when advising Mrs Connolly and used the disputed words in that advice.
- I consider the evidence of Mrs Connolly on this point. I have to say that, in general, I did not find Mrs Connolly a witness upon whose evidence I felt confident to rely. It is clear from the history I have already given that I have not seen all the statements given by Mrs Connolly in this case. From those that I have seen, I have obtained a developing and sometimes confusing or contradictory case. Similar comments may be made of her evidence before me including that given in cross-examination in respect of her medical and smoking history, the events leading up to, and of, the angiogram procedure, the extent of her recovery and the detail of her claim for damages. I consider that over the years, as a result of the undoubted misfortune of this angiogram procedure that went wrong, Mrs Connolly has persuaded herself of the correctness of a case on a number of issues in this case that are not correct and the question under review is one of them.
- I turn to the information sheet. It is agreed that this was misleading as noted by the experts. However, having considered all the evidence that Mrs Connolly had before she signed the consent form and considering the legal principles that I must follow as set out above, I agree with the opinion of the experts on this point although I would express the answer to the question slightly differently; I do not consider that Mrs Connolly's consent was vitiated by the information sheet.
- I will take the next two questions together.
(ii) When did dissection of the LAD occur in particular was it before or after the femoral approach was undertaken?
(iii) When in the sequence of events did Mrs Connolly suffer from the pain from which she complained in her right arm, chest, neck and back pain which she described as excruciating?
- The case that Mrs Connolly now firmly asserts is that the temporal relationship between the "excruciating" pain she described in her served witness statement at paragraph 44 was experienced by her after access to her arterial system was gained via the femoral route and this is most persuasive evidence that dissection occurred after that route was chosen. Supportive of this contention is said to be the fact that there is an absence of visual sightings of the dissection before access was sought by the femoral route and that such a dissection may be consequent upon insertion of a stent.
- This is the heart of the case on liability. As necessary planks of her case on liability, Mrs Connolly must persuade me on the balance of probability that the dissection occurred after the femoral route was undertaken; to do so, considering the experts agreement, she must also establish that the "excruciating" and diffuse pain she described was experienced by her after access to her arterial system was gained via the femoral route.
- On the evidence I have heard I am not so persuaded, indeed, in my judgment I am satisfied that the dissection and excruciating pain suffered by Mrs Connolly were suffered by her before access to her arterial system was gained via the femoral route.
- I reach this conclusion for a number of reasons. Firstly, I was impressed by, and accept, the evidence of Dr Freeman that it would be unusual for the artery to be in spasm for a long period of time and for the LAD to be in spasm with the other arteries still functioning normally. In his evidence, Dr Perry appeared to take the view that the occlusion of the LAD at the start of the procedure was coincidental spasm (not to be confused with the arterial spasm in the arm), and that the true damage, the dissection of the LAD, did not occur until later. However, he has not provided any reasons for this, other than that the damage is first identifiable on the imaging at 12.30 p.m.
- Secondly, I consider the weight of the evidence favours the conclusion that the "excruciating" pain described by Mrs Connolly was experienced by her before the femoral route was undertaken. I consider a proper consideration of all the medical records in the case supports that view. In particular Dr Mechery's report of the procedure which I consider clearly to be chronological, supports the fact that severe and diffuse pain was suffered by Mrs Connolly before the femoral approach was adopted. The drug record, and in particular the prescription of strong analgesics before the femoral route was adopted supports this view. Finally, I consider highly significant on this point what I might fairly describe as Mrs Connolly's developing account as to this matter.
- I am persuaded that until Mrs Connolly became aware of the significance of the point, her recollection of events did not include knowledge that the excruciating pain she suffered occurred after the femoral route was undertaken, or indeed even an awareness that the femoral route was undertaken. This chimes with the weight of the evidence that between 11.10 a.m. and 11.20 a.m. Mrs Connolly developed severe pain in her chest as a consequence of the occluded LAD, and as a result a number of drugs were administered, including diazepam and morphine.
- I should expand on my comment as to Mrs Connolly's "developing account" of this matter. In general terms, this claim has been characterised by the late service of witness evidence from Mrs Connolly; more specifically, the history already set out in relation to the attempts to introduce rebuttal evidence to deal with the note in Dr Perry's report as to Mrs Connolly's lack of knowledge of the femoral route being undertaken does little credit to her case. The most obvious and best opportunity to have dealt with this matter was in re-examination of Mrs Connolly; a familiar forensic step is to put to a witness whose evidence has been challenged on the basis of "recent invention" a previous record of the witnesses' evidence that contradicts that assertion. That was not done. The matter could have been dealt with by producing in re examination of Dr Perry the statement of Mrs Connolly referred to in his report to demonstrate that he had misinterpreted Mrs Connolly's evidence on this point. That was not done. It was not until closing that the initial attempt was made, as already described, to introduce a statement apparently given sometime in 2012, the final attempt being made in respect of a different statement. This whole history raises as many questions as it answers.
- In particular, what is the content of the statement of 2012? Mrs Connolly has now produced the statement dated 6 February 2013 that is consistent with an account of having been aware of the femoral approach on 19 June 2009. However, I agree with Mr Barnes contention that that statement adds to the impression that her evidence is unreliable, as her evidence on some key issues has become more entrenched with time as demonstrated by a comparison of the content of paragraphs 39, 54 and 56 of the statement dated 6 February 2013 with paragraphs 40, 55, and 57 of the statement dated 2 April 2014.
- In respect of this matter I consider the further evidence of Dr Perry about this. I have already raised the uncertainty as to which statement was provided to Dr Perry for the provision of his initial report bearing in mind his answers to the questions about this in cross-examination. In any event, that further evidence provides support for the conclusion that Mrs Connolly was unclear as to the events on 19 June 2009. As Mr Barnes contended to me, it is difficult to interpret Dr Perry's note on 14 February 2013, "wasn't sure of leg" other than as meaning that when he discussed the claim with the Claimant on 14 February 2013, she was not aware that they had changed the point of access to the femoral artery in the leg. Dr Perry's evidence in an e mail to Mrs Connolly's solicitor dated 26 March 2015 about this is as follows:
"My notes are mainly bullet points and in general confirm the statements in the witness statement. I have noted she was unsure of what was going I [sic] the leg meant(verbatim note ('Wasn't sure of leg').
I think this is what my sentence at para 1c 'she was unaware of a different arterial approach via the femoral artery' means. I think I meant she was unsure about the fact/concept one could go in the leg not that she was delirious to the point of not knowing it was happening at all."
- I do not find this persuasive.
- I further accept Mr Barnes contention that Dr Perry's notes are remarkable in their lack of analysis of any timing issues, which is significant in the context of this claim, whether it is because Mrs Connolly was not able to recall the timings, or because Dr Perry failed to understand the importance of the timing issues.
- I turn to the next question for my decision, namely,
(iv) Did Mrs Connolly withdraw her consent to the continuance of the procedure before access was attempted via the femoral route?
- Strictly, in the light of my above findings this question is largely, if not wholly academic, but I consider I should answer it. In my judgment, whilst I accept that so soon as Mrs Connolly started to suffer from excruciating and diffuse pain as a result of the performance of the angiogram the dissection and the occlusion of the LAD she became anxious, stressed, and complained of severe and diffuse pain, I am not persuaded that she withdrew her consent to its continuance. I note that none of the three witnesses involved in the procedure remember anything as significant as a withdrawal of consent. It is also significant that the Claimant did not complain that the angiography had been continued without her consent in the aftermath of the procedure.
- The next question is,
(v) Did Mrs Connolly lack capacity to withdraw her consent due to the effects of medication given to her and if so, what is the legal effect of that circumstance?
- Again, strictly, in the light of my above findings this question becomes academic but I will answer the question. In my judgment based in particular upon the evidence of Dr Freeman, I consider that she did lack capacity.
- The next question is,
(vi) Did an event that threatened Mrs Connolly's life occur before any withdrawal of her consent, and if it did, what was the legal effect of that happening?
- At the time the femoral approach was begun Mrs Connolly was in considerable pain. She had been given doses of morphine and diazepam. It was reasonable for Dr Mechery to proceed with the procedure in circumstances where he was faced with what he rightly regarded as a medical emergency. He knew that Mrs Connolly's LAD was occluded, but did not know at what point. That occlusion meant that a large portion of her heart was not being supplied with blood supply. If the blood supply was not quickly restored the potential consequences were permanent damage and death. It was imperative that time was not wasted in detailed explanation to a patient affected by excruciating pain and drugs as to the procedure upon which he was about to embark. In the light of the authorities outlined above I do not consider that Dr Mechery or any of the hospital staff were in breach of duty in undertaking the course of treatment that they did once the occlusion of the LAD was detected.
- I turn to the next question for my decision, namely,
(vii) On the premise that Mrs Connolly was given insufficient or misleading information before she consented to performance of the procedure, would she have refused an angiogram had she not been given that insufficient or misleading information?
- On the evidence before me I consider that she would not.
- The next question is,
(viii) On the premise that Mrs Connolly withdrew her consent to the continuance of the angiogram procedure after the radial approach was abandoned, would Mrs Connolly have consented to the continuation of the procedure had she been asked?
- Mrs Connolly's witness statement did not expressly deal with the circumstance she would have found herself in, namely that her LAD was occluded, that this had the potential to cause permanent damage or death and needed to be resolved without delay, and further angiography to examine the condition of the LAD was mandatory. Faced with this, I consider that the probability is that the she would have accepted the advice of those treating her, and would have consented to further angiography via the femoral approach. In any event, authority already referred to demonstrates that the question of what Mrs Connolly would have done if the procedure had been temporarily halted must be answered in part on an objective analysis and the only realistic conclusion on that basis is that she would have consented to the angiography continuing.
- I turn to the last question for my decision, namely,
(ix) Had the hospital staff halted the procedure when consent was withdrawn, would the outcome have been any different?
- In the light of my above answers this question is hypothetical, if not unreal. I have found that Mrs Connolly was properly consented for this procedure and that the dissection occurred before the femoral route was undertaken. Once the emergency arose, there would have been significant difficulties for Dr Mechery and his team in giving detailed explanation to Mrs Connolly of the emergency and the proposed further procedure and being convinced that Mrs Connolly was validly withdrawing her consent, by reason of the circumstances to which I have already referred. As confirmed by the experts, it was clearly reasonable for Dr Mechery to proceed with the procedure. However, answering the question as posed, in my judgment, the consequence of the hospital staff halting the procedure would have been the death of Mrs Connolly. Even on the postulate, against my finding of fact, that Dr Perry were to be correct that the dissection occurred during the insertion of the catheter by the femoral approach, the answer is probably the same. The expert evidence was that in the light of the undoubted occlusion of the LAD it was mandatory for Mrs Connolly's continuing proper care to insert a catheter in the femoral artery.
- It follows from the foregoing that I consider that Mrs Connolly's claim fails both on the issue of breach of duty and causation.
- However, as I have heard the evidence and submissions upon the issue of quantum, it would be prudent for me shortly to make findings on that evidence.
QUANTUM
GENERAL DAMAGES
- The detail of Mrs Connolly's treatment, present condition, and the prognosis appears from the medical reports and evidence before me. Mrs Connolly had a very unpleasant time, firstly in the Mayday hospital, then at King College Hospital and then recovering at home. However, on the evidence before me, although she continues to suffer from some residual disabilities, such as the fact that she is now required to take lifelong medication which exacerbates nose bleeds and heartburn from which she suffers, I consider that she has made a generally good recovery from this life threatening episode. I conclude that her condition was approaching her pre- procedure state within about three or four months of the procedure.
- Mrs Connolly's case is that her life expectancy has been reduced by 5 years based on the evidence of Mr Perry. Dr Freeman states that one year "may be pragmatically reasonable." I accept Dr Freeman's evidence on this point and award 1 year for loss of expectation of life.
- Mr Meredith Hardy contends that for this head of claim the award for general damages should fall into the Judicial College Guidelines for the assessment of General Damages in Personal Injury Cases bracket of £53,075 to £81,400 (with the uplift).
- I consider this to be unrealistic. In my judgment the proper assessment of this head of claim should be one of £25,000.
ENHANCEMENT FOR "AGGRAVATED DAMAGES" FOR BATTERY
- Mrs Connolly seeks an enhancement of her general damages for battery due to injury to her feelings. If I had found in Mrs Connolly's favour that by reason of the procedure being continued without her consent then I accept that the percentage increase contended for would be appropriate.
LOSS OF EARNINGS AND CARE CLAIMS
- Mrs Connolly's claims for loss of earnings and care are not supported in the Joint Statement of the cardiologists, nor by the evidence before me and I reject these claims.
OTHER LOSSES
- Mrs Connolly claims future treatment and miscellaneous expenses in the Schedule of Loss. The evidence in support of these claims is exiguous. Doing the best I can I will assess this loss at the sum of £250.
That completes my quantification of this claim but for the reasons already given, this claim is dismissed.
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URL: http://www.bailii.org/ew/cases/EWHC/QB/2015/1339.html