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You are here: BAILII >> Databases >> High Court of Ireland Decisions >> Tynan v Bon Secours Health System Company Ltd by Guarantee & Anor (Approved) [2025] IEHC 81 (11 February 2025) URL: http://www.bailii.org/ie/cases/IEHC/2025/2025_IEHC_81.html Cite as: [2025] IEHC 81 |
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[2025] IEHC 81
THE HIGH COURT
[Record No. 2019/8190P]
EILEEN TYNAN
PLAINTIFF
AND
BON SECOURS HEALTH SYSTEM COMPANY LIMITED BY GUARANTEE
AND
HEIKO KINDLER
DEFENDANTS
JUDGMENT of Mr Justice Paul Coffey delivered on the 11th day of February 2025
Introduction
1. Born in 1956, the plaintiff is a mother of three daughters and currently resides in Spain with her husband, where they are both retired. At the time relevant to these proceedings, the plaintiff and her husband were living in Cork.
2. The plaintiff claims damages for personal injury, alleging that on 25 July 2018, at the Bons Secours Hospital in Cork, the second named defendant, a consultant cardiologist, together with the hospital's cardiac nursing and technical team, wrongfully caused or allowed her to endure severe and unrelenting physical pain throughout a 54 minute procedure performed under local anaesthetic for the insertion of a pacemaker and the removal of a loop recorder which it is further alleged has caused her to suffer psychiatric injury.
3. Despite receiving the standard dosage of local anaesthetic, the plaintiff testified that she experienced excruciating pain which began immediately when Dr Kindler commenced the procedure and persisted throughout, ceasing only upon its completion. She further asserted that she was crying intensely and repeatedly informed Dr Kindler of her pain, pleading with him to stop and for help, to such an extent that she felt that she was shouting to the point of becoming hoarse. She stated that he either was not listening to her or dismissed her concerns, attributing the pain to "small veins" and urging her to "relax" because he needed "to do (the) procedure". While the plaintiff acknowledges that Dr Kindler offered her sedation and that fentanyl, a potent and fast acting opioid used for pain relief, was administered to her during the procedure, her evidence was that it did little more than to make her slightly drowsy and failed to alleviate her pain. She further stated that she felt isolated and ignored by the medical staff who were present at the time, describing the atmosphere as distressing, with a talk show playing on a radio and two nurses conversing away from her but not coming to her at all during the procedure despite seeing that she was in pain. Her evidence was that she felt deeply traumatised, angry, and abandoned by the staff's lack of response which she claims has caused her to suffer a psychiatric injury which her consultant psychiatrist has described as either PTSD or an adjustment disorder.
4. The defendants dispute the plaintiff's account of events, asserting that it amounts to an allegation of gross negligence that is neither credible nor coherent. They specifically deny that she communicated any significant or ongoing distress at the time or that the staff ignored or rejected her concerns, maintaining instead that the procedure was completed without any negligence. Dr Kindler's evidence was that, while he now acknowledges in hindsight that the plaintiff may have subjectively perceived her experience to have been traumatic, there was nothing, aside from one verbal expression of minor pain, said or done by the plaintiff at the time to indicate that she was experiencing trauma. He further stated that the procedure appeared straightforward, uneventful, and without complication, as reflected in the contemporaneous medical and nursing records. Three of the four other members of Dr Kindler's team who were present at the time gave evidence to the effect that they had no recollection either of the plaintiff, the procedure or any of the untoward events that are alleged by the plaintiff. The nurse who had primary responsibility for the plaintiff's welfare during the procedure further stated that had the plaintiff exhibited pain, distress or repeatedly requested Dr Kindler for assistance or to stop the procedure, as she claims, such concerns would have been promptly addressed and documented. The defendants acknowledge that the plaintiff was tearful at the end of the procedure and appeared emotional shortly afterwards upon being returned to the ward. However, they emphasise that during multiple checks conducted over a six hour period before her discharge, she reported no pain and exhibited no documented signs of trauma or distress.
Background
5. On 22 June 2017, the plaintiff experienced a blackout for 40 minutes which led to her admission to the Bon Secours Hospital in Cork ('the Hospital') where extensive medical investigations were conducted to determine the cause of her unprovoked loss of consciousness. Despite these efforts and the fact that she had experienced previous similar episodes, nothing abnormal was discovered and the underlying cause of the blackout remained unclear. As part of the diagnostic process, the plaintiff underwent an angiogram and a procedure to implant a loop recorder, both of which were performed by Dr Kindler on 27 June 2017.
6. The loop recorder, a small device inserted subcutaneously, was implanted to monitor and record the electrical activity of her heart over an extended period to detect any irregularities in her heartbeat which might have explained her blackout episode. Although the implantation procedure was relatively minor and not associated with pain, anxiety or any other complication, the plaintiff had elevated blood pressure throughout the procedure which appears to have been attributable to the plaintiff experiencing White Coat Hypertension, a syndrome whereby a patient experiences temporary elevated blood pressure readings in a clinical setting. Subsequent monitoring of the loop recorder showed intermittent pauses in the plaintiff's heart rhythm. However, these pauses were not associated with any further blackout episodes or reported symptoms.
Events leading to the procedure
7. On 5 July 2018, the plaintiff was reviewed by Dr Kindler. During this short meeting, the findings from the loop recorder and her medical history were considered and the plaintiff was advised that the implantation of a permanent pacemaker was necessary to regulate her heart rhythm by stimulating the heart in the event of a pause, thereby reducing the risk of future cardiac events. At this consultation, the plaintiff agreed to return to the Hospital on 25 July 2018 for a dual procedure under local anaesthetic for the implantation of a permanent pacemaker and the removal of the loop recorder. The plaintiff gave evidence that during her interaction with him over 10-15 minutes, Dr Kindler described the procedure as "very, very simple" and advised her that with local anaesthesia she would not experience "any pain, nothing at all". While he had no specific recollection of discussing the possibility of pain with the plaintiff, Dr Kindler gave evidence, which I accept, that he never would have said to a patient that a pacemaker insertion would be 100% pain free and that his usual practice was to inform the patient that the procedure would have painful moments. He said that he did not highlight the risk of pain as the risk of pain is minimal and because the procedure is generally well-tolerated under local anaesthesia.
8. It is not disputed that, while informing the plaintiff that the procedure would be performed under local anaesthesia with intravenous pain relief, if necessary, Dr Kindler did not offer her the option of sedation prior to the procedure or discuss its benefits and risks. He explained that, while he frequently administers sedation in the form of midazolam to 30-40% of his patients undergoing pacemaker implantation, he does not do so as a routine practice due to its potential for serious and unwanted side effects. His evidence was that the decision to use sedation is guided by clinical discretion based on patient presentation, and that in the plaintiff's case, there was no indication for its use as she exhibited no signs of anxiety, nor was any anxiety flagged in her medical history. The plaintiff stated that she was a strong and confident individual with no prior history of anxiety or related medical treatment.
9. Despite her repeated and consistent denials, including in her Replies to Notice for Particulars and in her responses to the two psychiatrists who assessed her for this case, that she had never experienced a prior mental injury or illness, the plaintiff's GP records, disclosed to the defendants on the fifth day of the trial, revealed otherwise. These records showed that, following an episode of breathlessness that required hospital admission in 2004, a letter from her treating physician to her then GP described her as suffering from anxiety and panic episodes, for which psychiatric assessment was recommended but declined. Additionally, after a road traffic accident in 2009, a psychiatrist diagnosed her with an anxiety state characterised by avoidance behaviour, hypervigilance, general anticipatory anxiety, and some depressive symptoms for which she was advised to go on a SSRI, a type of antidepressant medication, which she declined.
10. The plaintiff was admitted for the procedure at 7.25am on 25 July 2018 by Nurse Aileen Hickey who initiated the admission process by reviewing the plaintiff's medical history and general health to ensure that she was adequately prepared for the procedure. At 8.45am, the plaintiff signed an Informed Consent for the procedure in which she explicitly consented to the administration of "local" or "other anaesthetic" as deemed necessary by the attending anaesthetist. It is common case that anaesthesia can include the administration of analgesic and sedative drugs, including fentanyl, a drug that was subsequently administered to the plaintiff at 11.04am. Around 10.25am, the plaintiff was handed over to Nurse Marie Daly, who then continued with her preprocedural assessment. The plaintiff also underwent routine checks including her vital signs.
11. In preparation for the procedure, a nurse inserted an IV line or cannula into a vein in the plaintiff's arm to allow drugs or fluids to be delivered directly into the plaintiff's bloodstream as needed. The plaintiff described a subsequent incident in which a junior doctor came over to her and said that "we need to get a vein and take some blood". Her evidence was that when he was unable to get a vein, she told him that a nurse had already come over and taken blood from her. She said the doctor apologised and said he was a junior hospital doctor and "new on the job". The plaintiff stated that she replied, "that's okay" and described the interaction as being "the start of it."
12. Although it was not described as such by her, it is common case that in fact the junior hospital doctor was attempting a second but unnecessary cannulation of the plaintiff. When asked in cross-examination whether the attempted second cannulation was "a big deal" for her, the plaintiff responded "No, it wasn't...absolutely no...I'm just making the point what happened."
13. The incident was not documented in the hospital records. Dr Kindler testified that he was unaware of the interaction with the junior hospital doctor and that he had at all times proceeded on his assessment of the plaintiff as "a very stable patient" in whom he had observed no signs of anxiety before the procedure. However, in a later report that he prepared for his legal team in 2019, Dr Kindler stated that he considered it significant that the plaintiff entered the procedure "feeling some distress" from the cannulation incident, which he suggested may have influenced her perception of subsequent events. Elaborating on this in his evidence, Dr Kindler stated that with hindsight, if he had been made aware of the plaintiff's prior interaction with the junior hospital doctor or had been told by her that she was anxious or had a history of "severe anxiety", he "could" have given her sedation in the form of midazolam before going into the Cath Lab and would have checked her even more cautiously to make sure that she was comfortable throughout the procedure and "could" have had an anaesthetist on standby, if that was necessary. He indicated that his retrospective change of mind was based not merely on the cannulation incident but also the plaintiff's prior history of anxiety and panic attacks and her potential susceptibility to anxiety, all of which had been unknown to him at the time. He emphasised, however, that he would not have done anything differently with the information that was then available. He also suggested that the plaintiff could have informed him of the cannulisation incident and any resulting anxiety, as there was no indication that the junior doctor was aware that it had caused her distress. Neither the occurrence of the cannulisation incident or the failure of the junior hospital doctor or the nursing staff to communicate it to Dr Kindler were pleaded as Particulars of Negligence on the part of the hospital.
The Procedure
14. The dual procedure was carried out on 25 July 2018 in the cardiac catheterisation laboratory ('Cath Lab') at the Hospital. The Cath Lab was described in evidence as a room comparable in size to a standard operating theatre, equipped with advanced medical and imaging equipment, and staffed for cardiac procedures. A formal pause described in the notes as 'Time out' to wash hands, scrub up, and verify patient identity, procedure date, details, and all other relevant information took place at 10.42am. It is not in dispute that this preoperative period is also used by clinicians to communicate with the patient to assess how they are. The plaintiff's evidence was that other than preliminary niceties, there was very little said by Dr Kindler either before or during the procedure.
15. The plaintiff was fully conscious throughout the procedure. A team of five healthcare professionals was present, Dr Kindler as the lead cardiologist, a scrub nurse assisting with sterile instruments, a circulating nurse overseeing patient comfort, a cardiac physiologist monitoring cardiac data and a radiographer managing imaging equipment, all within earshot of the plaintiff. The physical layout was such that Dr Kindler was positioned on the left side of the plaintiff, the scrub nurse adjacent to him to his right, the physiologist to the left side of the plaintiff at the foot of the table, and beside her, the radiographer near the imaging controls. The circulating nurse, Nurse Daly, had no fixed position but took up a default position near the plaintiff's feet, close to a desk with a computer, unless she was checking on the patient, performing some other tasks or standing back when the Xray machine was being used. It is common case that she was the team member who was primarily responsible for observing the plaintiff and ensuring her wellbeing during the procedure. Her evidence was that her usual practice was to constantly check on and reassure patients during the procedure and to make a record of any untoward event or events, including any sort of serious distress on the part of the patient. She said there was no circumstance when she would stand off and not respond to a patient's complaint of pain or distress.
16. Throughout the procedure, the plaintiff was placed under a sterile paper drape which provided a limited opening near her head for necessary access and for maintaining sterility. The drape restricted the plaintiff's ability to see the medical team such that she had no eye contact with Dr Kindler who could not see her face during the procedure. The plaintiff was positioned on her back with her four limbs unrestrained and with her head tilted to the right, thereby facing away from Dr Kindler and the scrub nurse, and was for the duration of the procedure wholly reliant on the circulating nurse for observation of her wellbeing in the possible but unlikely event that she could not be heard above the ambient noise by the other medical staff. The circulating nurse was also responsible for recording the patient's vital signs during the procedure (between 10.37am and 11.35am). These readings were derived from a cardiac monitor and blood pressure pump connected to a lead that ran from the plaintiff's chest. The plaintiff also had an IV line running from her right arm for the infusion of drugs.
17. The ambient noise in the Cath Lab included sounds from medical equipment and a radio that was playing during the procedure what the plaintiff believed to be a chat show. Multiple voices could also be heard, including Dr Kindler, the plaintiff, and other staff, including the cardiac physiologist who intermittently gave out information regarding cardiac rhythm and lead placements. When asked whether it was possible that Dr Kindler might not have heard her, the plaintiff said that he was standing so near her that he must have heard "something" and that he must have heard "some cries". The evidence of the circulating nurse, Nurse Daly, was that everyone who is present in the Cath Lab for such a procedure, including the patient is within talking distance and that there was never a time in her 15 years working there that she could not hear a patient. Elaborating on this, she said that if a patient "mumbles", her usual practice was to go to the patient and to ask them to repeat what they had just said. Although she had no specific recollection of the plaintiff or her procedure, her evidence was that if the plaintiff was complaining, she would have been heard by her, Dr Kindler and the scrub nurse who was to his side. The plaintiff's evidence was that she was "really, really crying" and that she "felt that she was shouting" and was "hoarse" from asking Dr Kindler to stop.
18. The dual procedure commenced with the 'skin incision' for the insertion of the pacemaker, documented at 10.44am, and concluded at 11.38am, following the removal of the loop recorder. It is agreed that the procedure for the pacemaker implantation was completed at 11.25am, taking 41 minutes which it is agreed was unremarkable in its duration. In his evidence, Dr Kindler questioned the accuracy of the recorded skin incision time of 10.44am, stating that administering local anaesthetic to the area would have taken approximately 5/8 minutes, as the anaesthesia is infiltrated progressively to superficial and then deeper layers of the surgical field. He suggested that the recorded 'skin incision' time might refer to the time the needle was inserted to administer the local anaesthetic. However, the relevant entry was made by the circulating nurse, Nurse Marie Daly, who testified that her entry records the actual time the incision was made.
19. The procedure commenced with the incremental administration of a standard dose of 40mls of 1% lidocaine, a commonly used anaesthetic. Dr Kindler initially titrated 20mls to numb the tissues around the intended incision site. As the procedure progressed, he titrated an additional 17-18mls to numb the deeper layers incrementally, followed by a further 1-2mls to anaesthetise the incision site for the removal of the loop recorder. Lidocaine typically begins to act within minutes and depending on the dose, can provide effective anaesthesia for 45 minutes and upwards to several hours. The administration of a local anaesthetic typically involves some discomfort as the needle is inserted but this sensation is brief and diminishes as the anaesthetic takes effect.
20. While the plaintiff had no clear recollection of it, it is not in dispute that Dr Kindler tapped the affected area to test the effectiveness of the anaesthesia. His evidence was that, after he was satisfied that the anaesthesia was effective, he made a small nick to test for pain before proceeding to make a 5cm incision beneath the left collarbone. Dr Kindler stated that the plaintiff had no pain when he made the incision, explaining that if the anaesthetic not been effective, the resulting pain would have been so excruciating that the plaintiff would not have been able to tolerate it, likely reacting with such intensity that she would have jumped off the table and been heard "in the next room". After making the incision, Dr Kindler proceeded to use a surgical instrument to create a pocket for the pacemaker device above the muscle and below the skin, a process that involved dividing the tissue layers down to the pectoral muscle.
21. After creating the pacemaker pocket, Dr Kindler inserted two leads into the heart by threading them, with the assistance of guidewires, under Xray guidance into the subclavian vein. Access to the vein was achieved by dilating it and inserting a sheath, through which the leads were threaded and securely attached to the heart. His evidence was that even with effective anaesthesia, the use of the needle in the vicinity of the clavicle bone and the dilation of the vein can be painful for the patient. During the intermittent use of the Xray machine, nurses who do not need to be near the patient typically step back for radiation safety. The plaintiff's evidence appears to erroneously correlate this phase to the start of the procedure.
22. Dr Kindler gave evidence that during the second phase of the procedure, while guiding the needle into the subclavian vein or dilating the vein, the plaintiff expressed pain by saying "ouch" or "ow, that hurts". In response, he administered supplemental local anaesthetic and 25mcgs of fentanyl at 11.04am, a strong fast-acting potent opioid which acts within one to five minutes and which typically provides relief for up to five to ten minutes. The fentanyl was administered by Nurse Daly, under Dr Kindler's direction, from a vial containing 100mcgs via an IV cannula. Neither the reason for giving fentanyl nor the plaintiff's response to its administration were recorded in the medical or nursing notes. The evidence of Nurse Daly was that the plaintiff's expression of pain was not noted by her because the administration of fentanyl implies the presence of pain, even if not specifically documented. She said that pain would be noted in the nursing notes if it was ongoing, if the drug was not working, or if a further infusion of fentanyl was needed. She stated that under current practices, an intraoperative pain chart is now used in the Cath Lab to document pain scores and locations of pain but acknowledged that no pain chart was used during the procedure. Nurse Daly said that after an infusion of fentanyl, her usual practice is to assess the effectiveness of the pain relief and inform the consultant if additional medication is needed.
23. By 11.14am, when the fentanyl's effects would have subsided, the pacemaker insertion procedure was essentially complete apart from electrical testing and closure. Dr Kindler stated that, despite the plaintiff's small veins, she remained still, allowing him to locate the vein efficiently within a minute. He explained that after the vein was dilated, the remainder of the procedure was largely free of pain stimuli and relatively painless, including the threading of the pacemaker leads into the heart, as the heart does not have pain sensors.
24. After attaching the leads to the heart, Dr Kindler explained that he and the rest of the team stepped back while the cardiac physiologist tested the leads to confirm proper placement and electrical functionality. Stability testing involved Dr Kindler asking the plaintiff to breathe in and out to ensure proper lead placement. This phase of the procedure did not involve cutting or tissue manipulation and should not have caused more than minimal discomfort. The plaintiff's evidence was that when she was asked to do the breathing exercises, she kept saying "can you please stop". After the electrical testing of the leads, the pacemaker, a small battery-powered device, was connected to the leads and placed in the pocket created beneath the skin following which the wound was subsequently closed.
25. Following the completion of the pacemaker procedure, the team proceeded to remove the loop recorder in a relatively minor procedure which took approximately thirteen minutes. This involved a small incision of approximately 0.5cm with minimal tissue manipulation. Dr Kindler said that the removal of the loop recorder had a very low likelihood of causing any pain. The plaintiff's evidence appears to erroneously correlate this procedure with the administration of fentanyl at 11.04am.
26. Commenting on their likely response to patient distress or pain, Nurse Daly emphasised that the Cath Lab staff are "very patient-centred" and that all team members were attentive to patient needs. She stated that if the patient had cried out or asked for the procedure to stop, she or the team would have responded and any such distress would have been recorded in the nursing notes. As no such notes were made during the procedure, she inferred there were no significant issues or complaints of pain. In her evidence, the plaintiff stated that she was observed by the nursing staff from a distance. Conversely, Nurse Daly stated that, consistent with her usual practice, she would have frequently checked on the plaintiff, asking how she was feeling and responding to any complaints of pain. She stated that if the plaintiff had complained of pain, she would have informed Dr Kindler if he had not already heard it himself.
27. Throughout the procedure the plaintiff's vital signs were monitored with particular attention to her systolic blood pressure, heart rate and oxygenation. An AVPU score to assess a patient's level of consciousness was filled out before and after the plaintiff's procedure but there was no intraoperative record kept of any pain or distress experienced by the plaintiff during the procedure.
28. At 7.30am, just over three hours before the procedure, the plaintiff's systolic blood pressure was recorded at 165mmHg (normal is 120mmHg). It is agreed that this was due to White Coat Hypertension which the plaintiff had previously exhibited and which had been recognised and documented in her hospital records in 2017. Her baseline systolic blood pressure was recorded at 165mmHg at 10.37am, seven minutes before the procedure started. At 10.48am, four minutes after the skin incision was recorded as having been made, the plaintiff's systolic blood pressure spiked to 180mmHg but her heart rate remained relatively stable between 60 and 75 beats per minute. It thereafter dropped to 170mmHg at 10.53am and further fell again to 165mmHg at 11am. There was a second spike to 180mmHg at 11.05am, a minute after fentanyl was infused for pain, at which time her heart rate had risen to 75 beats per minute. Her systolic blood pressure then dropped to 170mmHg at 11.15am but rose again to 175mmHg at 11.25am where it remained at 11.35am, a minute after the procedure finished.
The postoperative period
29. The plaintiff's evidence was that when the procedure finished, the pain ceased but that she was crying inconsolably. Dr Kindler said that as he left the room, he was surprised to see that the plaintiff was in tears which he attributed to relief on the part of the plaintiff that the procedure was over. His evidence was that the plaintiff was being attended to by a nurse who was wiping her tears and so he left them undisturbed but agreed in answer to a question posed by the court that he should have checked on her to see for how long she had been crying and why. The member of the team who attended on the plaintiff appears to have been the cardiac physiologist, Clair Callanan who said that after the drape was removed, she noted a tear in the plaintiff's eye for which she offered the plaintiff a tissue. Her evidence was that she did not make a note of the interaction because it was not unusual for a patient to be a bit emotional or tearful following a procedure, sometimes due to a sense of relief that the procedure had ended. She did not recall any specific verbal exchange with the plaintiff about the tear. The plaintiff's evidence was that when he had finished the procedure, Dr Kindler said, "well done" and left the room. She said that a "nurse" then came over with a cloth and wiped her eyes. Her evidence was that she asked the nurse "please can you tell me why he didn't stop?" to which the nurse replied "I don't know". This alleged verbal exchange was not put to Clair Callinan in cross-examination, an omission that this court will consider when assessing the weight and credibility of the evidence.
30. At 11.50am the plaintiff was moved to the recovery room where she was assessed and found to meet the relevant discharge criteria. The plaintiff testified that she was inconsolable and crying when she was returned to the ward at 12.05pm. The contemporaneous note made by the ward nurse, Nurse Maeve Linehan, recorded that she was alert, oriented, "emotional", but not in pain. Nurse Linehan clarified that "emotional" meant that she was tearful or crying but that her emotional state was less than moderate or severe.
31. The plaintiff gave evidence that, after the procedure but before her discharge from the hospital, she had an exchange with a nurse on the ward regarding sedation. Her evidence was that on an occasion when the nurse came to her to take her blood pressure, she was crying and asked the nurse to look at her chart to see what Dr Kindler had given her because "it didn't work". She said the nurse had "a good look" at the chart and said, "you got very little sedation". This alleged verbal exchange was not put to Nurse Linehan in cross-examination, an omission that I will consider when assessing the weight and credibility of the evidence.
32. The plaintiff remained on the ward under routine observation with monitoring of her vital signs, including heart rate and blood pressure together with pain scores, until she was eventually discharged into the care of her husband at 6.20pm. The plaintiff's systolic blood pressure which had spiked twice to 180mmHg during the procedure, returned to a normal level on the ward by 2.25pm. Prior to this, she had received a routine dose of postoperative paracetamol at 2.10pm. There were no indications of acute pain, or any distress documented in the nursing notes either before or after its administration. Throughout the afternoon from 12.05pm to 5.40pm her pain assessments were recorded intermittently on seven occasions and consistently showed a pain score of 0/10.
33. At 5.25pm, Dr Lambert assessed the plaintiff and confirmed she was fit for discharge. Before leaving at 6.20pm, Nurse Hickey provided her with follow-up instructions, including postoperative care advice and warning signs that might need medical attention. Nurse Hickey stated that it was her usual practice to discuss discharge instructions thoroughly with the patient and document any questions or concerns raised. She confirmed that no issues or concerns were noted and that the plaintiff's recorded pain score at discharge was 0/10, indicating no expressed pain at that time. It was put to the plaintiff in cross-examination that if she had truly suffered the trauma she now claims, she would have expressed it before leaving the hospital. The plaintiff's evidence was that she just wanted to get out of the hospital as fast as she could and get home because she did not want to talk to anybody in the hospital.
34. Evidence was given as to the plaintiff's demeanour later that evening after she had returned to her home in Cork by her daughter Natasha. On the morning of 25 July 2018, Natasha had spoken by phone from Belgium to her mother and described their conversation as normal, with her mother appearing upbeat. Later that evening, Natasha received a phone call from her mother during which she found her in significant distress. Her level of upset was such that Natasha immediately contacted her husband and made the decision to return to Ireland with their children. She and her husband cancelled their professional commitments to support her mother, believing that something traumatic had occurred.
35. Natasha described her mother as typically strong, brave and the pillar of their family. However, after the procedure, her mother appeared to her fragile, anxious and emotionally broken. Upon returning to Ireland on 27 July 2018, Natasha observed her mother behaving unlike her usual self, describing her as being detached and not fully present. She found her mother sitting on the bed, crying, withdrawn which she compared to witnessing someone in grief. Natasha believes that the experience has left her mother fundamentally changed.
36. The plaintiff attended the first of numerous follow-up appointments at the hospital to have her pacemaker checked by a cardiac physiologist on 3 August 2018, but there is no documented record of any complaint. During cross-examination, when asked why she had not expressed her distress or reported her experience, she stated that she had, in fact, spoken to the nurse conducting the check-up. According to the plaintiff, the nurse inquired if she intended to pursue the matter further, to which she responded that she was unsure. It was subsequently put to her that the reviews are in fact conducted by a cardiac physiologist. The plaintiff's response was to the effect that there was little point complaining to somebody that was checking her pacemaker who was not there on the day of her ordeal.
The plaintiff's first documented complaint
37. On 7 August 2018, Mary Connor, a cardiac rehabilitation nurse, made a routine follow-up call to the plaintiff. During this call, the plaintiff told her that she was traumatised by the procedure and gave details of her experience. In her evidence, Nurse Connor said that she was extremely surprised, shocked, even horrified that any patient would be traumatised after any procedure and wrote down what she had been told by the plaintiff at her desk very soon after she talked to the plaintiff. Her handwritten note is the first documented record of the plaintiff's complaint. It records the following:
"Patient stated that she was 'traumatised' after her pacemaker insertion. Stated staff on the day ward were kind but an intern came to insert a line and was looking for a long time to get a vein when she already had a line in situ. Dr Kindler didn't talk to her pre procedure and said very little during procedure. There was a radio on in the Cath Lab with a talk show. 'Felt everything' during procedure and it was extremely painful. A drape covered her face, nobody explained things to her. Cried during the whole procedure and wasn't reassured by anyone until someone wiped her eyes with a cloth. Cried for 3 days after going home. Advised to put her concerns in writing to the Best Practice Department..."
38. Nurse Connor stated in evidence that she apologised to the plaintiff because she had not expected the plaintiff to have felt the way she did. She encouraged the plaintiff to submit her complaint in writing to the Best Practice Department for investigation.
39. In her account of her conversation with Nurse Connor, the plaintiff said that she broke down and told her "exactly what happened". Her evidence was that Nurse Connor apologised profusely and said she would go away and find out the reasons why it happened and why the nurses never came near her.
40. The following day, Mary Connor discussed the plaintiff's complaint with various members of the hospital staff, including Dr Kindler who she said was extremely surprised and could not recall anything traumatic happening to any of the patients in whom he put a pacemaker. He also offered to meet the plaintiff and discuss the issues raised by her.
41. Later, the same day, Nurse Connor made a further phone call to the plaintiff in which she informed the plaintiff of what she had done. She made a handwritten note of the conversation in which she recorded that the plaintiff appeared to be satisfied but did not want to take up the offer to meet Dr Kindler. During this conversation, Mary Connor reiterated her apology and reassured the plaintiff of the hospital's commitment to addressing her concerns and encouraged the plaintiff to formalise her complaint in writing. The plaintiff's evidence on this issue was to the effect that she did not escalate her concerns because she did not want to go near the hospital.
42. The plaintiff's account of this second telephone conversation differs from that of Nurse Connor's insofar as she said that Nurse Connor told her that the reason the nurses did not come near her during the procedure was because of the radiation in the Cath Lab. Nurse Connor's evidence was that she could not recall whether radiation was mentioned or mooted with the plaintiff as a possible reason why the nurses might not have come over to her side. Nurse Connor gave evidence that wearing radiation protection, such as lead aprons, is mandatory for staff in the Cath Lab during procedures involving Xray imaging. Evidence was also given by Professor O'Neill that the use of Xray is intermittent during lead insertion and that when used, staff members not directly involved with the immediate task, may step back from the patient to further reduce their exposure to radiation. Nurse Daly clarified that they were still within range to monitor the plaintiff's status and respond as necessary, even when stepping back during Xray use.
43. As a result of Nurse Connor's intervention, the practice in the Cath Lab has changed whereby the radio is only put on at the request of the patient. Otherwise there appears to have been no investigation of the incident.
Subsequent interactions between Dr Kindler and the plaintiff
44. By letter dated 1 August 2018, Dr Kindler wrote to the plaintiff's GP. Despite its date, the letter was initiated on the day of the procedure but completed after Nurse Connor had spoken to Dr Kindler following her conversation with the plaintiff on 7 August 2018. In the letter Dr Kindler erroneously stated that, in addition to local anaesthesia and fentanyl, he had used midazolam during the procedure, a benzodiazepine with sedative, anxiolytic (anti-anxiety) and amnesic effects, in addition to local anaesthetic and fentanyl. He further stated that the procedure was "uncomplicated and uneventful" but acknowledged that the plaintiff had told Mary Connor that she found it "very uncomfortable". In his evidence to the court, Dr Kindler said that he was surprised by the plaintiff's account of her experience as reported to him, as neither he nor any member of his team had witnessed any indication of severe pain or distress of any significance during the procedure.
45. The plaintiff's GP replied to Dr Kindler's by letter dated 22 August 2018 in which she said that the plaintiff had been with her the previous week and had said that she found the "whole experience of having the pacemaker inserted very traumatic as she was expecting it to be totally pain free" and claimed that "she could feel severe pain right throughout the procedure".
46. On 19 September 2018, and on the advice of her GP, the plaintiff met Dr Kindler at his rooms on Washington Street in Cork, accompanied by her husband. She stated in evidence that she found him a "gentleman" and said that he was upset and "couldn't apologise enough". When she told him that Nurse Connor had told her that the nurses avoided her because of radiation in the room, he said "that's nonsense...they are equipped to deal with radiation in the room". The plaintiff said she replied, "then who's telling lies? Somebody is not telling the truth here". According to the plaintiff, Dr Kindler conveyed that he, too, wanted answers about what had occurred. She said that he suggested that the sedation might have come from a faulty batch, though he considered this unlikely. She gave disputed evidence that Dr Kindler said that he should have stopped the procedure and called in an anaesthetist, and unchallenged evidence that he apologised "profusely" and that he further stated that he would like answers to what happened because it was "his job" to do the operation and that it was "up to the nurses" to look after the plaintiff.
47. In his evidence, Dr Kindler described his meeting with the plaintiff as "very emotional" during which the plaintiff came across as "very genuine" and that he had no reason not to believe that she had experienced what she described but that he did not recall it "quiet that way". He accepted that it was clear in his mind when he met her on 19 September 2018 that the plaintiff had "a very unpleasant experience" and that she was "aware of everything". His evidence was to the effect that he was not aware of anything untoward during the procedure but was aware that the plaintiff was crying and in tears at its conclusion. He stated that although he did not see it that way at the time, the plaintiff "obviously felt traumatised during the procedure, she thought she was going through a rough time". However, on the second day of giving evidence Dr Kindler qualified his testimony somewhat to suggest that what the plaintiff experienced was an anxiety response to a genuine but subjective sense of pain. While accepting that the procedure has occasional but unavoidable moments of pain and discomfort, he rejected the suggestion that the pain could have been excruciating, or that it could have lasted throughout the procedure or that it would simply cease once the procedure finished.
48. By letter dated 1 October 2018, Dr Kindler wrote to the plaintiff's GP stating as follows:
"She clearly had a very unpleasant experience and tells me that she was aware of 'everything' despite the fact that we had given her a good dose of local anaesthetic including local, as well as sedation and I have expressed my sincere sympathy and apologised for her suffering."
49. The letter further indicated that if there was to be a need for a similar procedure in the future, general anaesthetic might be considered to prevent such issues reoccurring.
The plaintiff's distress following the procedure
50. The plaintiff gave evidence that in the weeks following the procedure she was emotionally distraught, experiencing frequent flashbacks. She stated that going through airport security triggered intense panic because of her awareness of the pacemaker in her chest and the memory of the traumatic experience during its insertion, an anxiety that was compounded by a feeling of vulnerability associated with the medical device.
51. The plaintiff was prescribed calming tablets by her GP who in 2019 referred her to Dr Eugene Morgan, consultant psychiatrist. He was of the opinion that the plaintiff was suffering either from adjustment disorder or PTSD and prescribed her antidepressants and referred her for counselling. She abandoned both courses of treatment after a short period, finding neither to be of benefit in alleviating her symptoms. She continued to experience severe emotional distress. The plaintiff's evidence was that her overall wellbeing and confidence were profoundly impacted. Her evidence was that she became less social, feeling persistently anxious and struggling to participate in activities she once enjoyed. She stated that the trauma resulted in notable changes to her personality and relationships, especially causing strain in her marriage. She brought forward a decision that had been made to move to Spain by two years because she felt she needed to escape the memories and environment associated with the procedure. Her evidence was that the relocation did not ease her emotional suffering. During this difficult period the plaintiff also turned to alcohol as a coping mechanism.
Expert evidence
52. There was consensus that pacemaker implantations under local anaesthetic are generally well tolerated procedures and that lidocaine, when administered in the dosage given to a patient of the plaintiff's weight, usually provides adequate pain relief for the duration of the procedure. It is further not in dispute that although lidocaine is often given in combination with midazolam, it is not mandatory to use midazolam because midazolam carries risks and is used at the discretion of the clinician.
53. The expert evidence indicates that severe pain is neither a typical nor an expected risk of the procedure when performed correctly with effective local anaesthesia. If severe pain does occur, it likely indicates a failure of the anaesthesia, which would have been evident to the operating team through patient feedback, overt movement, or physiological responses. All experts recognised that transient mild to moderate pain is a known and foreseeable risk of a pacemaker procedure even with adequate and effective anaesthesia, particularly when the clinician is accessing or dilating the subclavian vein for lead insertion. It is further recognised that local anaesthesia alone might not be effective for all patients and may need to be supplemented with intravenous analgesia, typically in the form of fentanyl, or sedation, typically in the form of midazolam, or a combination of both with doses adjusted depending on the patient's response.
54. All experts agreed that verbal interaction with the patient during the procedure is essential to assess and respond to pain, anxiety, or discomfort effectively. They agreed that verbal reports from the patient are critical in assessing pain levels during a conscious procedure such as a pacemaker implantation. They further agreed that dynamic monitoring of the patient during the procedure particularly by the circulating nurse was critical to monitoring and documenting patient wellbeing. The evidence of the defendant's nursing expert was that, in addition to responding to any verbal or physical signs of pain, the circulating nurse should check on the patient under the drape every 10 minutes.
55. While all experts agreed that the plaintiff's elevated blood pressure was consistent with but not diagnostic of anxiety, stress, or pain, the defendant's experts pointed out that the patient's heartrate remain normal during the procedure which they argued was inconsistent with severe pain. They further emphasised that the absence of postoperative pain complaints contradicted the plaintiff's claim of severe procedural pain. However, it was argued by a defence expert that acute procedural pain may not necessarily result in ongoing postoperative pain, especially if local anaesthesia was effective during the latter part of the procedure. The defendant's experts further expressed scepticism as to the veracity of the plaintiff's claims, not merely relying on physiological data as to her normal heartrate but also her lack of movement and compliance during the procedure and the lack of postoperative complaints as evidence against the claim of unrelieved severe pain. All agreed however, that her physiological markers, whether they discounted severe pain or otherwise were consistent with but not diagnostic of anxiety or stress.
Evidence called on behalf of the plaintiff
Dr Ken Power, consultant anaesthetist
56. Dr Power described the procedure as typically performed under local anaesthesia (lidocaine), with optional intravenous analgesia and/or sedation, as needed the purpose of which is to enable the patient to tolerate the procedure, to remain still and comfortable throughout while preserving airway reflexes and maintaining consciousness. He said that the role and mechanism of local anaesthesia is to eliminate sharp pain in the operative area, providing numbness for 1-2 hours. His evidence was that while sufficient nerve blockage ensures that the patient feels no pain, local anaesthesia is not always effective in which case he said it was incumbent on the clinician to supplement it with intravenous analgesia and sedation or, further titration of lidocaine. Dr Power provided a detailed explanation about how anaesthetic agents, such as lidocaine, work by blocking nerve fibres to prevent pain, but he acknowledged that if a patient experiences sharp pain, additional medication, such as fentanyl or midazolam, may be necessary to maintain comfort. His testimony highlighted the importance of vigilant patient monitoring, particularly by the circulating nurse, and the potential need for dynamic adjustment of medication based on the patient's responses.
57. He stated that administering 40mls of 1% lidocaine was reasonable for a 60kg patient as was the plaintiff. His evidence was that before making an incision, it is incumbent on the clinician to make sure that the local anaesthetic is effective by gently tapping the area in which the anaesthesia has been infiltrated with a small gauge needle to ensure that the sensation of sharp pain has been abolished. Even when local anaesthesia is generally effective, Dr Power emphasised that complete pain prevention and avoidance of any discomfort cannot be guaranteed, particularly when the clinician is accessing or dilating the vein for lead insertion or creating the pocket for the pacemaker or if the clinician directly hits a nerve or impinges on a bone.
58. He noted that the plaintiff's blood pressure rose from a baseline of 165/80 before the procedure at 10.37am to 180/90 four minutes into the procedure at 10.48am, with a rise to 170 systolic and then a subsequent rise to 180 systolic at 11.05am. He contended that while some elevation of blood pressure during such a procedure is typical, a reading of 180 systolic was significant. He argued that the elevation was inconsistent with a relaxed, pain free patient and suggested that persistent systolic blood pressure levels of 160-180 later dropping to 120 post procedure, was compatible with but not diagnostic of pain or discomfort. He explained that this was caused by the release of catecholamines, triggering the "fight-or-flight" response, during which adrenaline is released, leading to an increased heart rate and elevated blood pressure.
59. His evidence was that in a scenario such as that contended for by the plaintiff, where a local anaesthetic is proving ineffective, despite an adequate dose having been given, with the patient becoming distressed because of pain, it is incumbent on the clinician to "do something pharmacologically". He accepted that in taking the action needed, it was a matter for the clinician to determine whether the local anaesthetic should be supplemented with intravenous analgesia or sedation or a combination of both. His evidence was that where a patient is distressed with pain and is anxious, combining both an opiate (such as fentanyl) with a benzodiazepine (such as midazolam) is a well-established "almost universally accepted approach". He characterised the 25mcgs of fentanyl that was infused into the plaintiff at 11.04am as a cautious and modest dose, with room for the titration of further increments up to 150mcgs, in combination with midazolam, to relieve anxiety, if pain or anxiety persisted. Dr Power accepted that midazolam, though effective, carries risks like nausea and somnolence and is used at the discretion of the clinician. His evidence was that fentanyl, when infused, takes two to five minutes to take full effect and that its impact lasts for five to ten minutes. His evidence was that after it has been infused, ongoing patient monitoring was crucial due to variability in individual responses to sedatives like fentanyl. He emphasised the importance of titrating medications like fentanyl in response to patient distress and maintaining close communication with the patient to monitor their condition throughout the procedure.
60. He emphasised the crucial role of the circulating nurse in maintaining the patient's comfort, particularly given that the clinician was focused on a technically challenging procedure and the fact that the plaintiff's face was covered with a drape, reducing her ability to communicate discomfort. He specified that it was the responsibility of the circulating nurse to regularly check the patient's comfort and breathing, especially amid potential communication barriers like a drape and background noise.
61. Dr Power said that pain is very much a subjective experience and that it is what it is to the patient. His evidence was that if the plaintiff was crying during the procedure such that the procedure is clearly not being tolerated, the procedure should have been paused and additional fentanyl and, if necessary, midazolam, administered, with doses adjusted based on the patient's response. He stated that it was only if the incremental combination of analgesia and anxiolysis did not alleviate the patient's distress that an anaesthetist would be called in to give an anaesthetic agent to allow the procedure to be completed.
62. On the issue of whether there should have been a recording of "no pain" if there was in fact no pain elicited by Nurse Daly from the plaintiff, Dr Power said he would not expect to see meticulous recording of things that did not happen but would expect to see "reference to significant events or complications".
Dr Arvinder Kurbaan, consultant cardiologist
63. His evidence was that in skilled hands, pacemaker procedure from first incision to stitching takes approximately 35-40 minutes. In cross-examination he agreed that the procedure time in this case was consistent with a relatively straightforward insertion of a dual chambered pacemaker and did not indicate an unduly prolonged procedure. He described the consent process for the procedure as an ongoing dialogue starting from initial discussions and continuing up to the procedure itself. Dr Kurbaan agreed that in his report he expressed the opinion that the consent was "appropriate".
64. He advocated for the early administration of an anxiolytic, such as midazolam, to pre-emptively break cycles of pain and anxiety. His evidence was that he prefers using midazolam at the outset to prevent the need for reactive pain and distress management during the procedure. He observed in this case, midazolam was not administered, but there was no contraindication to its use. He accepted, however, that the giving of midazolam is not mandated and that clinicians have a degree of discretion as to whether it is used or not. His evidence was that the plaintiff's history of anxiety, White Coat Hypertension and issues during cannulation should have prompted the administration of midazolam early to help the plaintiff relax. He said anxiety can exacerbate pain perception and may even make a tolerable stimulus feel significantly more painful. He agreed in cross-examination that there was nothing in his instructing solicitor's letter to say that the plaintiff was an anxious person at the time of the procedure. He also accepted that he did have the relevant record relating to the plaintiff experiencing White Coat Hypertension but did not comment upon it as being a relevant factor either in his original report or in any of his subsequent letters. He accepted in cross-examination that in his expert report and three letters for the court, he made no criticism of the failure to use midazolam in this case.
65. Dr Kurbaan observed that the plaintiff's blood pressure remained high during the procedure which he attributed to distress, anxiety or pain, or a combination of the above. In re-examination he said that it is likely that the plaintiff had some pain during the procedure which contributed to her blood pressure in addition to being anxious and distressed. His evidence was that the intraoperative blood pressure readings suggested unresolved anxiety, discomfort or pain, with fentanyl having minimal impact on alleviating the plaintiff's distress. He stated that the plaintiff's elevated blood pressure during the procedure indicated untreated distress which only normalised once she returned to the ward. He accepted in cross-examination that he made no reference to the plaintiff's intraoperative hypertension as a potential indicator of pain or anxiety in any of his expert reports for the court. When it was pointed out to him that the plaintiff's heartbeat was normal throughout the procedure, Dr Kurbaan said that while one "on average" would expect heart rate and blood pressure to go up simultaneously in response to pain, it is not always the case that they do.
66. He stated that good practice required documentation of both fentanyl administration and its effects, yet no such detail was recorded. He emphasised the importance of patient communication and dynamic patient monitoring, stating that in cases where a patient is experiencing persistent distress, verbal reassurances, active listening, and appropriate medication adjustments are crucial components of care. The lack of follow-up observations after the infusion of fentanyl suggested to him that there were shortcomings in maintaining optimal patient comfort and safety during the procedure. In answer to the questions asked by the court, he said that pain is a "very very complex thing" and that he was very cautious of attributing everything just to pain. He said that anxiety with nothing more could cause a perception of pain but added that there still needed to be a stimulus albeit that a stimulus of 1/10 may feel like a 10/10.
Nurse Mary Kelly, nursing expert
67. Nurse Kelly's evidence highlighted the critical role of the circulating nurse in monitoring and documenting patient wellbeing during the procedure, emphasising the need for adherence to the hospital's safety and documentation protocols.
68. Her evidence stressed that the circulating nurse has primary responsibility for the patient's wellbeing, including monitoring any verbal signs of discomfort and documenting all events during the procedure. She said that if the plaintiff expressed pain, the circulating nurse was obliged to respond, document it and report it to the clinician. She stated that this record keeping was critical for patient's safety. Her evidence was that the hospital Pain Management Policy mandates using a pain chart to monitor and document the patient's comfort, coping and tolerance during the procedure, and yet noted that no such chart or any documentation of intraoperative pain is present in this case.
69. She stated that if the patient is reasonably distressed or verbally requesting help, the circulating nurse should have provided support and relayed her condition to the clinician. Her evidence was that the circulating nurse's duty involved periodic checks on the patient, maintaining documentation of her condition and that failure to do so would constitute substandard care, particularly if the nurse was unable to see or hear the patient adequately. She stressed the importance of documenting all medication administered, including fentanyl and asserted that it was the duty of the circulating nurse to monitor the patient's response to such medication to ensure its effectiveness after administration. She said this information should have been relayed to the clinician to adjust pain management as necessary.
70. She noted an inconsistency between the recorded lack of pain immediately after the procedure and the entry in the nursing notes which recorded that she was "emotional". She suggested that an inquiry into why the plaintiff was emotional ought to have been made and documented but that neither was done. She expressed surprise that no incident report was made, or outcome recorded despite the verbal and written concerns that were raised by the plaintiff which she considered a major lapse in patient's safety and protocols. She underscored that verbal and written patient complaints must be taken seriously, and that the absence of an investigation or incident report deviated from standard safety practices. She expressed surprise that no records were produced from case discussions that Nurse Connor had with hospital staff, criticising this as a failure in risk management.
Evidence called on behalf of the defendants
Professor James O'Neill, consultant cardiologist
71. He described the procedure as safe and successful with an excellent clinical outcome with the result that the plaintiff has had no blackouts since 2018. His evidence was that the standard of care does not require separate consent forms both for the procedure and sedation and that such is not the practice in Ireland. He said that the standard of care merely requires the clinician to discuss the benefits and risks of putting in a pacemaker and does not require a discussion of midazolam or no midazolam. He said that what is required is that the clinician ought to assure the patient that they will make the procedure as comfortable as they can and to ask the patient whether they have any questions.
72. He said the plaintiff in this case gave her written consent to "the administration of general, local or other anaesthetics as may be necessary" which he took to mean the entirety of the medications that was to be and was provided to her.
73. His evidence was that it is not possible to perform a pacemaker procedure without a degree of discomfort. He said that accessing the vein with a sheath to insert the leads involved accessing an area which is difficult to get adequately anaesthetised as the clinician does not want to infiltrate in proximity to the vasculature to avoid putting lidocaine into somebody's vein.
74. The evidence of Professor O'Neill was that the administration of 40mls of lidocaine and 25mcg of fentanyl was within typical clinical practice. The fentanyl dosage was on the lower end but reasonable, he said, as clinicians are trained to start with minimal doses and titrate as necessary to minimise toxicity, to avoid unwanted potential side effects and to have the patient up and about and moving as quickly as possible after the procedure. Although no sedation in the form of midazolam was administered, Professor O'Neill said this was a valid approach within the range of accepted practice which encompasses a variety of approaches which include lidocaine without any other agent, lidocaine in combination with fentanyl, and lidocaine with a combination of sedation with fentanyl. While sedation in the form of midazolam was not used, he said it was within the standard of care not to administer it unless deemed necessary based on individual patient's circumstances. He noted the absence of any documented psychiatric history which he argued was relevant to the treatment approach. His evidence was that he would not give sedation merely because the patient had a difficult experience with cannulation unless the patient was verbalising anxiety. He clarified that while many practitioners use midazolam in combination with fentanyl, its administration is not mandatory and the absence of sedation was not a deviation from the standard of care. He also said that Dr Kindler's suggestion of using general anaesthesia for future procedures did not necessarily imply an acknowledgement of negligence but could reflect a cautious approach to avoid similar distress.
75. He observed that blood pressure readings spiked to 160-180 systolic during the procedure but normalised afterwards. He opined that elevated blood pressure is common during invasive procedures due to stress or pain but did not necessarily indicate severe pain having regard to the plaintiff's stable heartrate. His evidence was that pain typically leads to changes in heartrate which were not observed in this case, suggesting that the plaintiff may not have been experiencing significant pain during the procedure. He also noted that if the plaintiff's claims of severe distress are accurate, it would be difficult to complete the procedure without interruption given the technical precision required. He said that if a patient cries out, he did not believe that any right minded doctor or even human being would not respond and that he could not imagine a situation where a patient is crying out in pain and it is not recorded.
76. He emphasised that clinicians must monitor and respond to patient's pain and discomfort by titrating additional lidocaine or fentanyl as required. He noted the absence of documented pain levels during the procedure which he stated was routine, as significant pain only would have to be recorded. He highlighted that no evidence of distress was documented immediately after the procedure and stated that the absence of complaints until later interactions with Mary Connor was a significant factor in his assessment. He emphasised the importance of communication between the clinician and the patient to monitor comfort and ensure the patient is informed of what to expect.
77. While he acknowledged the importance of patient communication and the potential for elevated blood pressure to suggest pain, his evidence overall was to the effect that the procedural approach was reasonable and in line with accepted practice. Professor O'Neill stated that some discomfort is inherent to the procedure with the clinician's real time assessment of the patient's pain levels being the primary factor in determining pain management adjustments. He stated that verbal communication from the patient is essential to determine if they are in pain, visual observation alone being insufficient for an accurate assessment.
Dr Michael O'Dwyer, consultant anaesthetist
78. He said that pain is subjective and cannot be objectively measured and is best determined through patient communication. His evidence was that physiological markers, such as heartrate and blood pressure, may provide supporting evidence but they are not of themselves diagnostic of pain.
79. His said that in a pain scenario the body responds by releasing adrenaline and catecholamines as part of the "fight-or-flight" response to acute pain or stress. His evidence was that the release of adrenaline causes the blood vessels to constrict and the heart to beat faster such that in a typical adrenaline-driven response, blood pressure and heartrate should rise together. Accordingly, significant elevation in one without a corresponding increase in the other would be unusual.
80. Dr O'Dwyer noted that while the plaintiff's blood pressure was elevated during the procedure (with readings up to 180 systolic), her heartrate remained normal (60-80 bpm). He argued this lack of correlation between elevated blood pressure and heartrate was inconsistent with severe acute pain caused by adrenaline release. His opinion was that the plaintiff's physiological response of normal heartrate with elevated blood pressure was more likely attributable to anxiety, stress, or other non-pain related factors, rather than severe and prolonged pain.
81. He said that if the local anaesthetic was ineffective from the outset, the plaintiff would likely have experienced significant pain during the incision such that there would also be behavioural indicators suggesting the plaintiff was in severe pain. His evidence was that severe pain without effective anaesthesia would likely result in substantial movement and noncompliance from the patient, making it difficult for the clinician to continue the procedure. He also said that it would have been difficult for the clinician not to notice if the patient was moving due to severe pain because any movement caused by pain would have disrupted the procedure including the placement of the pacemaker.
82. He said that excruciating pain over a prolonged duration would also have raised both blood pressure and heartrate simultaneously but in this case, while elevated blood pressure was noted, the heartrate remained normal which he said was inconsistent with severe pain. Dr O'Dwyer also stated that if lidocaine had been ineffective during the procedure the damaged tissues into which the pacemaker box and leads were inserted would have remained painful immediately after the procedure. His evidence was there would be a degree of postoperative pain in the first few hours following the procedure given the nature of the tissue damage caused by the implantation. He noted that the plaintiff's pain score was recorded at zero postoperatively which he said strongly suggested that the anaesthesia had been effective during the procedure. He argued that the absence of pain after the procedure was inconsistent with the claims of severe prolonged pain during the procedure due to ineffective anaesthesia. If lidocaine had not worked during the procedure, it would not have suddenly become effective postoperatively. This lack of reported postoperative pain reinforced his conclusion that the anaesthesia was appropriately administered and effective during the procedure.
83. He said that there are unavoidable painful moments in a pacemaker implantation procedure even where effective local anaesthesia has been administered. He said that anxiety can exacerbate pain and vice versa and that high blood pressure may reflect pain but said that that would only be so if the patient was reporting it during the procedure. He accepted that the aborted IV canulation attempt may have caused stress to the plaintiff, contributing to elevated blood pressure or anxiety. He also acknowledged that in his letter of 1 August 2018 to the plaintiff's GP, Dr Kindler suggested the plaintiff had a negative experience but emphasised that the reporting of pain during the procedure was critical to determining its severity. He stated that while anxiety could exacerbate pain, the plaintiff's behaviour and physiological responses including heartrate and blood pressure did not correlate with severe pain. His evidence was that the anaesthesia and drugs used were appropriate in the absence of the plaintiff expressing pain and discomfort.
84. He emphasised that midazolam is a sedative and not an analgesic and would not be appropriate for treating expressed pain. He regarded the 25mcgs of fentanyl administered at 11.04am as a small but appropriate starting dose, balancing the risk of significant adverse side effects such as respiratory depression, confusion and delirium. His evidence was that verbal confirmation of pain is the most reliable mechanism for determining discomfort, far surpassing physiological indicators. His evidence was that the absence of consistent verbal reports of severe pain during the procedure undermined the plaintiff's claims of prolonged discomfort. He also stated that if severe pain had been present throughout, it would have caused observable physiological and behavioural signs which were absent from what was documented in this case.
Mary Perryman, nursing expert
85. Her evidence was that, assuming without deciding that the circulating nurse checked on the patient every ten minutes during the procedure, that would accord with good nursing practice. Her review of the hospital records found no pain related entries in the nursing notes. She stated that given the absence of documentation regarding pain it was likely that no significant distress occurred during the procedure. She highlighted that if pain had been expressed by the plaintiff during the procedure a "P" would have been recorded in the notes but no such record was made. She stated that if an adverse event occurred, it should have been recorded in the postoperative pain scores and nursing notes. She indicated that if fentanyl was administered due to pain, this fact should be documented, and she stated that the patient's breathing and pain should be monitored following the plaintiff crying at the end of the procedure should also have been recorded but not so if all that was observed was a tear in her eye.
Liability
The law
86. In Morrissey & Anor. v Health Service Executive & Ors. [2020] IESC 6, Clarke CJ stated that the starting point in any professional negligence case requires the identification of the "standard of approach" which would have been applied by a professional of the appropriate standing or skill as the person to whom the allegation of negligence is made. Accordingly, in a clinical negligence action, unless it is established that an accepted practice complained of is inherently defective, the court's role is limited to evaluating the evidence provided by the relevant professionals regarding the standard of care they consider appropriate for someone of the defendant's expertise and standing. In such cases, it is the medical profession which sets the standard of care for doctors, just as it is the nursing profession that does so for nurses. In Morrissey, Clarke CJ further affirmed that the test established in Dunne (An Infant) v National Maternity Hospital [1989] IR 91 remains the foundation for determining the legal standard of care against which all claims of clinical negligence are assessed, stating that the test can be reduced "to one overarching principle with a number of subsidiary considerations which impact on the application of that overarching particular in particular circumstances."
87. It is not in dispute that, if the court accepts the plaintiff's account of events, negligence by both defendants would be established.
Issues to be decided
88. The plaintiff's primary complaint, as outlined in her Personal Injury Summons, is that the defendants were negligent and in breach of duty in failing to provide adequate anaesthesia and analgesia and in failing to properly monitor her which it is alleged resulted in the plaintiff suffering unnecessary pain and distress which subsequently caused psychiatric injury.
89. Five additional Notices of Further Particulars of Negligence were subsequently served by the plaintiff's solicitors on the defendants, the most recent of which was served, unverified by affidavit and without the leave of the court, on the ninth day of the trial. For the first time, it introduced a new assertion that the causal agent for the plaintiff's alleged trauma was anxiety which it is alleged caused the plaintiff to get into "the cycle of pain and distress (trauma) encountered". It further alleged that the defendants wrongfully failed to pre-empt her alleged anxiety by informing her of her option to elect for midazolam preoperatively, or alternatively, failed to alleviate it by administering midazolam in response to her elevated blood pressure and White Coat Hypertension which it alleged the defendants negligently overlooked as indicators of anxiety. It is further alleged that defendants failed to obtain the plaintiff's informed consent under the Hospital's Adult Sedation Policy by neglecting to inform her about the benefits and risks of procedural sedation.
90. The defendants reserved their position regarding this final Notice of Further Particulars of Negligence and, following the conclusion of the trial, have justifiably argued that the new allegations are neither grounded in the claims previously pleaded in the Personal Injury Summons nor arise from any evidence given by or on behalf of the plaintiff prior to service of the Notice. They contend that an application to amend the Personal Injury Summons is therefore required which they oppose. The plaintiff has responded by asserting that the contested particulars were prompted by the unexpected testimony of Dr Kindler, who stated that, had he been aware of the cannulation incident, he would have taken a "vastly different approach" and administered sedation in the form of midazolam at the commencement of the procedure.
91. I am satisfied that the contested particulars do not naturally flow from the facts and issues already pleaded in the Personal Injuries Summons such that they introduce new and unrelated allegations that require an amendment of the pleadings. Had the defendants raised an objection during the trial when the contested particulars were first served, I would, had such an application been made, have directed the plaintiff to make a formal application to amend her pleadings and to swear an affidavit verifying the relevant particulars pursuant to s.14 of the Civil Liability and Courts Act 2004. However, as the defendants allowed the case to proceed to conclusion without making such a request, I will, in fairness to the plaintiff, deal with this issue with a degree of latitude that would not otherwise have been available.
92. Case law establishes that a court has a discretion to allow even late amendments to pleadings, however, it is a discretion that must be exercised judicially, with due consideration of all relevant principles and the evidential context in which the application is made. Courts recognise that plaintiffs in medical negligence cases may face inherent disadvantages, as critical facts, especially medical or technical details, often emerge late through discovery, disclosure, or expert testimony. A late application may also arise, as appears to be the basis of the application in this case, to reflect or capture what is perceived to be a concession made in evidence. However, the decision to grant such applications typically depends on factors such as the timing of the request, the reason for the delay, any potential prejudice to the opposing party, and the broader interests of justice.
93. Although it is suggested that the contested particulars were prompted by Dr Kindler's unexpected testimony, they neither stem from facts previously unknown to the plaintiff nor reflect any concession perceived from that evidence. While the defendants were aware of the cannulation incident and its potential to cause distress to the plaintiff, so too was the plaintiff who was in a far better position than Dr Kindler to provide evidence as to how it impacted on her during the procedure. Moreover, and more critically, the contested particulars make no reference to the cannulation incident or suggest that it was distressing to the plaintiff in any way. Furthermore, the plaintiff's cardiology expert made no criticism of the consent process or the failure to use midazolam in any of the four opinions he prepared for the court, despite having addressed the issue of consent in his initial report and being aware of the plaintiff's elevated blood pressure during the procedure and susceptibility to White Coat Hypertension. Consequently, the particulars neither reflect nor naturally flow from Dr Kindler's evidence but rather seek to introduce an entirely new basis of complaint on the ninth day of a 15-day hearing, and therefore, at an intolerably late stage in the proceedings.
94. I must nonetheless take into account that the defendants were aware of the cannulation incident and its potential to cause distress to the plaintiff. Furthermore, the defendants raised no objection to additional Particulars of Negligence that were served on 30 August 2024 which included related allegations that the defendants failed to perform a preprocedure assessment or to obtain the plaintiff's consent for preprocedure sedation in accordance with the hospital's policies. I also have the benefit of hindsight, from which it appears that defendants have been able to address and respond to the issues of consent, the cannulation incident, anxiety, blood pressure elevation and White Coat Hypertension, at least in a general way, without the need for an adjournment, significant changes to their case or additional evidence. For all these reasons, I will consider the issues raised to ensure that the plaintiff is given the opportunity to present her best case. However, the court has a fundamental duty at all times to uphold the integrity and fairness of the trial process. Accordingly, I will revisit my ruling should any potentially adverse findings of fact be made regarding the newly introduced allegation of anxiety, particularly if such findings arise from a distinct issue of which the defendants had no prior notice, or if they raise additional factual or medical issues that were not specifically or adequately addressed during the trial.
95. The plaintiff has also raised additional complaints in two prior sets of particulars, alleging a failure by the defendants to record her pain during the procedure. As this allegation does not involve a causative breach of duty, I will address it but only to the extent necessary when evaluating the evidence relating to the plaintiff's primary complaint (issue (3) below).
96. I will consider all the issues I have specified in the format outlined below:
(1) whether there was a failure to obtain the plaintiff's informed consent for procedural sedation by reason of Dr Kindler's alleged wrongful failure to inform her of the option of midazolam;
(2) whether the plaintiff experienced anxiety as a result of the cannulisation incident, and if so, whether Dr Kindler knew or ought to have recognised that she was anxious such that he wrongfully failed to alleviate her anxiety through preprocedural sedation;
(3) whether the defendants wrongfully failed to provide adequate anaesthesia and analgesia and failed to properly monitor the plaintiff thereby causing the plaintiff unnecessary pain and distress.
Alleged failure to obtain informed consent for procedural sedation by reason of Dr Kindler's alleged wrongful failure to give her the option of midazolam
97. It is clear from the expert medical evidence which I accept, that although midazolam is often administered preprocedurally to manage anxiety during a pacemaker insertion under local anaesthesia, its use is not mandatory, particularly given its associated disadvantages and risks, such as prolonged sedation and respiratory depression. Rather, its administration is a matter of clinical discretion, with the clinician assessing on a case-by-case basis whether the specific needs of a patient, such as the expression of significant anxiety, justify assuming those disadvantages and risks.
98. As the plaintiff did not express anxiety to Dr Kindler before the procedure, her lawyers instead seek to argue that she ought to have been given the option of preprocedural sedation in the form of midazolam as part of the assessment and consenting process required for the giving of fentanyl under the Adult Sedation Policy of the first named defendant. The plaintiff relies on the Policy to argue that, because fentanyl at a dosage of 25mcgs is classified as a sedative under its terms, its administration by Dr Kindler during the procedure, albeit as an analgesic, imposed upon him a duty to educate her before the procedure about the benefits and risks of sedation and thereby to inform her of her option of preprocedural midazolam in order to procure her consent for the giving of fentanyl.
99. The relevant sections of the Policy are as follows:
"It is the responsibility of the Consultant administering sedation to gain informed consent for the procedure and sedation in accordance with the hospitals informed Consent Policy...
7.1 The Consultant documents the planned procedure. Informed consent is obtained by the Consultant which includes the education of the patient on the risk, benefits and alternatives to procedural sedation.
7.2 Candidates for sedation are those patients who must undergo painful or difficult procedures where cooperation and or comfort will be difficult or impossible without pharmacological support."
100. Hospital policies serve an important role as internal operational guidelines designed to promote best practise within healthcare institutions. However, they do not by their nature create enforceable rights or liabilities unless explicitly incorporated into a patient care contract, of which there is no evidence in this case. While these policies provide a framework for clinicians, they do not override the exercise of clinical autonomy in the interests of patient safety or replace clinical judgment by the standard of care prescribed by law.
101. Professor O'Neill gave unchallenged evidence that the standard of care in Ireland does not require separate consent forms both for the procedure and sedation. His evidence was that the standard of care merely requires the clinician to discuss the benefits and risks of putting in a pacemaker and does not require a discussion of "midazolam or no midazolam". I accept this evidence insofar as it pertains to this case which involved a minor procedure performed under local anaesthetic without the use of preprocedural sedation. Professor O'Neill also noted that the plaintiff signed a combined Informed Consent in which she gave her consent both to the procedure and to "the administration of general, local or other anaesthetics as may be necessary" which, it is agreed, can include the administration of analgesic and sedative drugs, including fentanyl, the only pain management drug administered to the plaintiff intraoperatively, aside from the local anaesthetic.
102. Assuming without deciding that the Policy does create legally enforceable rights and duties, I am nonetheless satisfied that the Policy is of no application in the evidential context of this case. While fentanyl at a dosage of 25mcgs is classified as a sedative under the Policy, its administration in this case was as an analgesic and not as a sedative to manage the plaintiff's expressed pain. This is the proper context in which the failure of Dr Kindler to discuss sedation with the plaintiff must be considered. Just as midazolam alone is insufficient to address expressed pain, fentanyl alone is insufficient to achieve full procedural sedation. At higher doses, fentanyl can produce sedative effects, but these are secondary to its primary function as an analgesic. In this case, it is agreed that fentanyl was administered in a low dose such that the sedation thereby caused was merely minimal. Critically, it was administered as an analgesic to address expressed pain and not to address anxiety or to induce sedation. Absent evidence that the plaintiff was a 'candidate' for sedation or that Dr Kindler planned to use sedation either in the form of fentanyl or midazolam before or during the procedure, I am satisfied that the Policy is of no application to this case.
103. Even assuming that Dr Kindler was as part of the consent process legally required to discuss the benefits and risks of procedural sedation and to provide the option of midazolam, a failure to do so would serve only to invalidate the plaintiff's consent to the administration of fentanyl. Insofar as there may be any complaint about the use of fentanyl, it is without merit, as the plaintiff's primary complaint is not that its administration violated her patient autonomy or that it ought not to have been given, but rather that it ought to have been administered at a higher dosage.
104. Accordingly, I find that Dr Kindler's failure to provide information to the plaintiff about midazolam, or to offer it, did not constitute a breach of duty or invalidate her consent either to the administration of fentanyl or to the procedure. Assuming without deciding that I am incorrect in arriving at this conclusion, I am further satisfied that the plaintiff has failed to give any evidence upon which I could reasonably be satisfied that she would likely have opted for sedation if it had been offered to her.
Whether the plaintiff was suffering from anxiety as a result of the cannulation incident and, if so, whether Dr Kindler knew or ought to have known that she was suffering from anxiety such that he ought to have relieved her anxiety by administering preprocedural sedation
105. The plaintiff alleges that the defendants did not properly assess her condition on the morning of the procedure, including her emotional and physical state and the effect of the cannulation incident shortly beforehand. The supporting evidence relied upon by the plaintiff is the admitted fact that a junior doctor attempted to insert a second cannula unnecessarily, allegedly causing distress to the plaintiff who described it as being "the start of it", an incident that was not communicated to Dr Kindler, who later conceded that it would have altered his approach. The plaintiff further relies on the fact that her interaction with Dr Kindler on the day was perfunctory, offering no substantive discussion of her alleged anxiety. Reliance is also placed on the expert evidence which it is alleged highlights the importance of preprocedure assessments to ensure that proper sedation and analgesia are given.
106. The plaintiff's contention rests on the premise that she was made anxious by the cannulation incident and that the defendants either knew or ought to have known of her alleged anxiety, despite the fact that she neither expressed anxiety nor mentioned the cannulation incident to Dr Kindler.
107. It ought to be acknowledged at the outset that any possible anxiety on the part of the plaintiff is not identified as an issue or even mentioned in any of the five expert medical reports procured on behalf of the plaintiff, even though these reports were undoubtedly prepared based on instructions carefully taken by her solicitors from the plaintiff. Dr Kurbaan agreed that there was nothing in the letter of instruction from the plaintiff's solicitor that suggested that the plaintiff was anxious at the time of the procedure. He also accepted that although he had the relevant record relating to the plaintiff experiencing White Coat Hypertension, he did not comment upon it as being a relevant factor in any of the opinions he prepared for the court. Neither he nor Dr Power in their expert reports made any criticism of the failure to use midazolam in this case. Although Dr Power did refer to the cannulation incident in his report, he did not suggest that the incident caused the plaintiff anxiety. Critically neither expert suggested that anxiety was an issue that Dr Kindler ought to have anticipated or addressed during the procedure.
108. The referral letter dated 2 June 2017 from the plaintiff's GP to the hospital, made no mention of any psychiatric history or propensity to anxiety. Instead, it stated that her overall health was "very good". Furthermore, the plaintiff did not experience or report any anxiety during the subsequent loop recorder procedure The plaintiff described herself in her evidence as a "very, very strong and confident" person prior to the procedure, denying any history of anxiety, panic attacks, or seeking medical attention for anxiety. She did not mention the cannulisation incident or a history of anxiety of any kind to either of the psychiatrists who examined her. Her evidence did not suggest that she experienced anxiety on the day of the procedure beyond the typical level of apprehension expected of anyone undergoing a cardiac procedure of this nature, nor did it indicate that she would have opted for sedation if it had been offered.
109. It is undisputed that, while the plaintiff was not specifically screened for anxiety, she was not recorded as reporting any such symptoms to either Nurse Hickey or Nurse Daly who reviewed her medical history and general health after her admission to the hospital at 7.25am on the day of the procedure. Nurse Daly testified that if any anxiety had been identified, the usual practice of the team would have been to notify Dr Kindler who could have prescribed sedation.
110. While it was suggested that her hospital records from 2017 referenced anxiety of which the nurses and Dr Kindler ought to have been aware, the relevant records merely pertain to her natural concern over the unexplained cause of the blackout that the plaintiff had experienced at that time, and do not contain any diagnosis or indication of pathological anxiety. Although her records did show that the plaintiff was aware that she had White Coat Hypertension, a common anxiety related phenomenon that is not generally considered pathological, the plaintiff gave evidence that it was not a concern for her at the time and that she did not mention it to Dr Kindler. Furthermore, the syndrome had been present during the procedure in 2017, during which she was recorded as having hypertensive blood pressure but reported neither anxiety nor pain.
111. Before examining the evidence, it is important to highlight that neither of the medical experts who gave evidence on this issue indicated that knowledge of the cannulation incident alone warranted the administer midazolam. Dr Kurbaan's evidence was that it was not the incident in isolation but rather a combination of factors- including the plaintiff's medical history of anxiety, White Coat Hypertension and difficulties during cannulation, that should have prompted the early administration of midazolam to help the plaintiff to relax. Professor O'Neill's evidence was that he would not administer sedation solely because a patient had a difficult experience with cannulation unless the patient was actively verbalising anxiety at the time. It is important to highlight that, when elaborating his evidence on this issue, Dr Kindler indicated that his retrospective change of mind was influenced by the plaintiff's previous history of anxiety and panic attacks as well as any possible distress resulting from the cannulation incident, both of which he was unaware of at the time of the procedure.
112. Shortly before the procedure, a junior doctor negligently and without justification attempted to insert a cannula into the plaintiff's arm to provide preprocedural antibiotics when a cannula had already been inserted. In her description of the incident, the plaintiff did not suggest that the junior doctor did anything other than search for a vein, with no suggestion that he punctured her skin or drew blood. When cross-examined as to whether the second attempted cannulation was a "big deal" for her, the plaintiff firmly denied that it was, stating "No, it wasn't...absolutely no...I am just making the point what happened." There is no suggestion from this that the incident made her anxious or unsettled her to a degree that was over and above the anxiety that any ordinary person would have had facing into a cardiac procedure. It is in this context that her description of the interaction as being "the start of it" is to be understood as a retrospective comment by her about when things started to go wrong overall, and not evidence of the onset of an anxiety that she never claimed and indeed which she denied when cross-examined.
113. Neither the junior hospital doctor nor Dr Kindler were aware of the plaintiff's susceptibility to anxiety as disclosed by her medical records from 2004 and 2009. Absent such knowledge, any preprocedural assessment for anxiety could only have relied on her self-reporting. The plaintiff has not given evidence of reporting anxiety or exhibiting any sign of preprocedural anxiety to either the junior hospital doctor or Dr Kindler that ought to have been recorded or acted upon. Insofar as there is a dispute in relation to when he first became aware of the incident, I am satisfied that Dr Kindler's knowledge of the incident was retrospective. Insofar as it is suggested that Dr Kindler ought to have been aware of the plaintiff's previous mental health issues which she repeatedly denied in her verified Replies to Notice for Particulars and in her evidence, I can find no legal or evidential basis for this suggestion, not least because her lawyers have asserted in their written submissions that her psychiatric history is not material to this case.
114. For the reasons given, I reject this ground of complaint.
Alleged failure to provide adequate anaesthesia and analgesia and alleged failure to properly monitor the plaintiff
115. The plaintiff has sought to advance this contention by relying on her testimony to the effect that she repeatedly cried out on in pain and asked for the procedure to stop, the fact that there is no documentation of her alleged pain or discomfort during the procedure, her elevated systolic blood pressure readings (170-180mmHg) during the procedure which it is contended align with pain and distress, and the expert evidence to the effect that the response to her alleged continuing severe pain should have involved titration of further analgesia or escalating sedation measures. The plaintiff further relies on the fact that she was observed crying at the end of the procedure and on a nursing note which recorded the plaintiff as being "emotional" shortly after the procedure which it is contended is consistent with her pain and distress. She further alleges a failure of the nursing staff to monitor and communicate with her throughout the procedure and specifically a failure to observe her closely for signs of pain and distress or to communicate such signs to Dr Kindler. The plaintiff specifically relies on her testimony to the effect that she recalled no meaningful interaction with the nurses during the procedure, the hospital policy entitled 'Care of a patient for the Insertion of an Intracardiac Device' which specifies that the circulating nurse's role includes ensuring patient comfort and accurate documentation and expert evidence to the effect that the absence of active monitoring would constitute a breach of duty. The plaintiff further relies on the absence of intraoperative notes to record pain levels to suggest that her monitoring was inadequate.
116. Only the plaintiff and Dr Kindler have a recollection of the procedure of which they have given sharply conflicting accounts. The plaintiff claims that she endured excruciating pain throughout, crying intensely and repeatedly voicing her distress with bitter complaints directed at Dr Kindler and others present yet insists that her crying and pleas for relief were ignored. She further maintained that her severe pain ceased immediately after the procedure but did so without any further pharmacological intervention. By contrast, Dr Kindler denied that the plaintiff exhibited any signs of pain, either verbal or nonverbal, during the procedure, apart from a single expression of transient pain in response to which he titrated further anaesthesia and administered fentanyl at 11.04am. He acknowledged observing the plaintiff crying after the procedure had concluded and retrospectively accepted that, while there were no outward signs of distress during the procedure, the plaintiff subjectively experienced trauma which he attributes to a heightened anxiety response.
117. Assessing the credibility of these conflicting accounts requires me to consider their internal coherence and consistency together with their alignment with the probabilities that emerge from an evaluation of the broader body of evidence relating to the surrounding circumstances of this case.
Internal coherence and consistency
118. I found the plaintiff to be a very pleasant lady who is sincere in her belief as to the anguish she claims to have suffered. However, her recollection of the procedure was fragmented and incoherent, marked by an inability to recall key details and significant confusion about the sequence of events.
119. The plaintiff's account suggests that Dr Kindler began the procedure immediately after introducing himself and omits any reference to the administration of the local anaesthetic or the testing of its efficacy, both of which are undisputed. Additionally, the plaintiff attributed pain allegedly experienced at the very start of the procedure to phases of the dual procedure that clearly occurred during its middle and end. Her evidence mistakenly conflates the second phase of the pacemaker implantation, involving vein access and lead insertion, with the entirely separate and subsequent procedure for the removal of the loop recorder. It further misrepresents these distinct events as having occurred simultaneously at the beginning of the procedure for the pacemaker implantation at which point she further erroneously suggested that sedation was offered.
120. The plaintiff's evidence, underpinning these observations, was as follows:
"(after scrubbing his hands Dr Kindler came over to her and) said 'good morning', I'm going to start the procedure now'. And I said, 'okay'. And he started. And the minute he started I said, 'Dr Kindler, I can feel it'. He said, 'it's okay, take a deep breath'. I said, 'no, but I can honestly feel it'. He said, 'your veins are very small'. He was taking the loop recorder out to put in the pacemaker. I said 'please, I can feel the pain'. He said 'do you want something else? I don't know, sedation, calming, whatever. I said, 'give me whatever'".
121. The plaintiff also provided inaccurate evidence regarding her experience of anxiety, denying on oath that she had previously experienced anxiety or panic attacks or had seen a doctor for either condition. On the contrary, the plaintiff had been admitted to hospital in 2004, during which she experienced ongoing anxiety and panic attacks. Following a road traffic accident in 2008, she was seen and assessed by a psychiatrist in 2009 who diagnosed her with an anxiety state and advised anti-depressant medication. Despite this, the plaintiff denied any history of mental injury or illness in her Replies to Notice for Particulars of 4 December 2019 and 20 January 2020, both of which were verified on affidavit. Like the defendants' expert in psychiatry, Dr Kelly, who gave evidence on this issue, I find it very difficult to understand how anyone could forget having attended a psychiatrist and particularly so if they made a diagnosis and advised treatment.
122. In the light of the above, it may be reasonable to suggest that the plaintiff's evidence raises questions about her reliability as a historian, particularly regarding the clarity of her memory of the procedure and all or any evidence that she gave in relation to the issue of anxiety.
123. Dr Kindler struck me as an empathetic and competent clinician. While his memory of the procedure is clear and coherent, it is to be noted that he has nonetheless provided three somewhat differing accounts regarding whether, and to what extent, the plaintiff exhibited pain during the procedure. In his original Defence, verified on affidavit, Dr Kindler asserted that "while subjectively the plaintiff may have found the procedure uncomfortable, objectively the level of discomfort was not more than reasonably expected under the circumstances." In July 2024, he delivered an Amended Defence acknowledging, consistent with his sworn evidence, that the plaintiff made "one transient complaint of pain during the procedure which was promptly attended to." During the trial, a Professional Statement made by Dr Kindler on 9 July 2019 was introduced into evidence, suggesting that the plaintiff expressed discomfort, albeit not pain or significant pain, on more than one occasion insofar as it recorded that "each time Ms Tynan did express discomfort, we acted with additional doses of analgesics."
124. Dr Kindler made numerous errors in recording important facts relating to the procedure. In his note of the procedure, Dr Kindler erroneously referred to the administration of 20ml of lidocaine (it was 40ml) and omitted any reference to the fentanyl that was infused at 11.04am. Having incorrectly informed the plaintiff's GP by letter initiated on the day of the procedure that he had given midazolam during the procedure, he failed to correct that error in his letter dated 1 October 2018 when replying to the GP's letter dated 22 August 2018. Furthermore, in the report that he prepared for his legal team in 2019, he suggested that he gave additional analgesia, Paracetamol 1g IV, intraoperatively, when in fact the relevant dose was given postoperatively at 2.10pm.
The general body of evidence.
125. There is no contemporaneous medical or nursing record documenting the occurrence of any untoward event or events during the procedure. Proper medical and nursing practice requires that significant or concerning events, including physical pain or emotional distress, are documented. The absence of such record would typically tend to imply that no such events occurred. However, in this case, it is alleged by the plaintiff that there was a persistent and total failure to record any of the plaintiff's ongoing complaints of severe pain which she alleges she voiced throughout the entirety of the procedure. Absent any challenge to the good standing, professional competence and experience of the Cath Lab team, I find this allegation inherently implausible, as it implies a deliberate, if not concerted, ongoing failure by all team members over the course of the 54-minute procedure to perform a simple, straightforward but fundamental duty. The credibility of this allegation is further undermined by the fact that Nurse Daly, the senior cardiac nurse responsible for making such entries in the nursing notes, was clearly monitoring and actively documenting the plaintiff's progress through the procedure, as evidenced by her regular recording of all the plaintiff's vital signs in the intraoperative medical record. Her diligent attention to these duties suggests that she was likely adhering to her usual practices throughout the procedure which, according to her evidence, includes frequently checking on the patient by approaching them directly and asking how they are. I also accept as inherently credible her testimony that she would not remain distant from a patient who was expressing pain. Taken together, this evidence tends to suggest that Nurse Daly would likely have documented any expressions of pain or crying had they occurred.
126. Three of the four other member of the Cath Lab team present during the procedure gave evidence, while the fourth, the scrub nurse, was unable to testify due to medical reasons which the plaintiff has not sought to criticise. None of the witnesses, all of whom were within speaking distance of the plaintiff, have any recollection of the procedure itself or anything said or done by the plaintiff during it. Even the physiologist, who recalled noticing a tear in the plaintiff's eye at the end of the procedure and offering her a tissue, has no memory of the procedure beyond that observation. All the witnesses came across as compassionate healthcare professionals who would naturally have been inclined to intervene and show empathy towards the plaintiff, if she had been heard or observed in any distress, and even more so if she had been in the unrelenting excruciating pain that she claims to have repeatedly verbalised. Their absence of memory is of itself significant, as the events as described by the plaintiff, if they occurred, would have been extraordinary and impossible either to ignore or to forget. In the absence of any evidence of collusion, their evidence tends to suggest that the plaintiff did not repeatedly verbalise or manifest unrelenting and excruciating pain throughout the procedure and further tends to suggest that the procedure was likely to have been significantly less eventful than portrayed by the plaintiff.
127. It is not in dispute that the pacemaker procedure was of normal duration. This suggests that the Cath Lab team were able to perform their tasks effectively and efficiently which in turn suggests that the plaintiff was cooperative and compliant throughout. It is also undisputed that the procedure was performed safely and successfully, an outcome that required the plaintiff to remain still during its technically demanding but potentially painful initial stages, including the incision, tissue division for pocket creation, and the accessing, dilating, and threading of the subclavian vein under Xray guidance for lead insertion. This evidence tends to support the inference that the plaintiff tolerated the procedure well and weighs against the plaintiff's claim that she experienced unbearable pain throughout. It also tends to suggest that the plaintiff had been adequately anaesthetised from the outset, as ineffective or inadequate anaesthesia would likely have resulted in intolerable pain from the 5cm incision, resulting in obvious and unmistakable physical movements and unforgettable vocal expression of agony and distress. Somewhat tellingly, the plaintiff did not give a graphic or any description of the incision itself, her reaction to it, or any verbal exchanges she had with Dr Kindler or the Cath Lab team at the time. Had she experienced the full pain of the incision at the outset of the procedure, the expert evidence suggests that she would likely have become uncooperative which would likely have resulted in significant delays or even the abandonment of the procedure.
128. After lead insertion, it is highly unlikely that the plaintiff could have experienced excruciating or any significant pain thereafter, as the remaining phases of the pacemaker procedure involve no further cutting or tissue manipulation but are for the most part taken up with electrical testing. By this stage, the potential sources of significant pain, such as incision, tissue dissection, and lead placement, have all occurred during the earlier stages of the procedure. Any pain during the final phases would therefore typically arise from residual discomfort caused by the initial cutting and manipulation of tissues rather than from the testing phase itself which is primarily technical and minimally invasive. The absence of active tissue trauma during these remaining stages tends to undermine the credibility of continuing severe and unrelenting pain from physical trauma at that time. Furthermore, the plaintiff acknowledged that, toward the end of the pacemaker procedure, Dr Kindler instructed her to perform specific breathing exercises to test the pacemaker's functionality which she completed without difficulty. Such an ability indicates a level of comfort and cooperation inconsistent with the presence of substantial pain or anxiety.
129. Similarly, the removal of the loop recorder which followed, was a minimally invasive procedure requiring a small, almost negligible incision to extract the device which is merely the size of two matchsticks. Compared to the cutting and tissue manipulation involved in a pacemaker insertion, this procedure carries a significantly lower potential for significant pain. Any residual pain experienced by the plaintiff during the removal of the loop recorder would most likely be attributable to the tissue trauma sustained during the initial stages of the pacemaker insertion, and not the loop recorder removal itself. Taken together, this evidence tends to undermine the plaintiff's claim that she experienced ongoing excruciating or any significant pain at any stage following the insertion of the pacemaker leads.
130. The expert evidence in this case establishes that if a patient were to experience excruciating and unrelenting pain during a pacemaker insertion procedure, as the plaintiff claims she did, it is likely to be reflected in their physiological data. Specifically, such pain would usually, although not always, result in both elevated blood pressure and a marked increase in heart rate which are driven simultaneously by adrenaline release. In this case, however, while there is evidence of hypertension, including two spikes in blood pressure reaching 180mmHg from a preoperative baseline of 165mmHg, there is no corresponding evidence of an increase in the plaintiff's heart rate above normal limits. This absence of tachycardia is evidence which is inconsistent with the likelihood that the plaintiff experienced the severe and continuous pain she has described.
131. The medical experts did agree, however, that elevated systolic blood pressure without an increase in heart rate can be an indicator of pain, anxiety or stress but more likely, anxiety and stress. Although none of the medical experts professed expertise in pain, they further concur that pain is subjective, and that there is an interplay between anxiety and pain such that anxiety can amplify pain, even to an excruciating level. However, anxiety-induced perception of pain will typically not arise without a pain stimulus which was minimally present after lead insertion and will similarly be reflected in the physiological data due to triggering the body's 'fight-or-flight' response, thereby causing the release of adrenaline to elevate not only blood pressure but also heart rate, particularly if the perception of pain is severe and unrelenting. The absence of tachycardia, therefore, suggests that even if the plaintiff experienced a perception of pain that was driven by anxiety, it was not experienced as excruciating, still less unrelenting excruciating pain.
132. The physiological data nonetheless indicates that the plaintiff had sustained elevated blood pressure during the entirety of the procedure, ranging from 165 to 180mmHg, with an average of approximately 172.5mmHg. While these readings are consistent with but not diagnostic of continuous and unrelieved anxiety, the systolic blood pressure is broadly similar to that recorded in the 2017 procedure, when the plaintiff reported no pain or anxiety, and the elevations were attributed to White Coat Hypertension. What is different about this procedure, however, is that the plaintiff was observed to be tearful or crying both at the conclusion of the procedure and upon her return to the ward at 12.05pm. Although there is no evidence to suggest that there was anything alarming about her demeanour, her crying at these times, combined with her elevated blood pressure, suggests that the plaintiff did experience anxiety and trauma to some degree during the procedure, even if it was not overtly expressed or visibly apparent.
133. The plaintiff reported a complete cessation of pain immediately after the procedure, despite alleging continuous excruciating pain throughout and receiving no further pharmacological intervention at its conclusion. The expert evidence of Dr O'Dwyer, which I accept, suggests that this provides evidence that the local anaesthetic administered to the plaintiff was adequate and effective. If the plaintiff had truly endured such severe pain throughout the procedure due to inadequate or inadequate anaesthesia, the resulting pain would be attributable to physical trauma caused by the incision, tissue dissection and manipulation, pain that does not resolve immediately upon the conclusion of the procedure. Instead such pain would likely persist until the natural healing process began or until post operative pain relief measures were provided.
134. Following the conclusion of the procedure at 11.35am, the plaintiff was returned to the ward at 12.05pm where postoperative analgesia in the form of paracetamol was not administered until 2.10pm. During the intervening period, when her only pain management cover consisted of intraoperative local anaesthesia (the effects of fentanyl having likely worn off by 11.14am), the plaintiff was assessed and reported no pain at 12.05pm, 12.15pm, 12.45pm, and 1.30pm. The fact that the plaintiff consistently reported no pain before receiving further pain relief, provides evidence which suggests that the local anaesthesia administered during the procedure was effective in managing physical pain, and that any previous distress experienced by the plaintiff was unrelated to physical trauma or the adequacy or effectiveness of the anaesthesia that was administered to her.
135. It is not in dispute that the plaintiff expressed pain at approximately 11.04am, at which fentanyl was administered in what it is agreed was a relatively small dose, 25mcgs. Dr Kindler gave unchallenged evidence that this expression of pain occurred as he was attempting to access and dilate the subclavian vain. This confirms that the plaintiff did experience pain during the procedure but at a stage when, even with adequate and effective anaesthesia, there is a potential for pain, because, as Professor O'Neill explained, the relevant area cannot be fully anaesthetised due to its proximity to the subclavian vein. Thus, the expression of pain at this point is not necessarily indicative of inadequate or ineffective anaesthesia but is consistent with the known limits of local anaesthesia in the anatomical context in which Dr Kindler was working. The modest level of the dose suggests that the plaintiff's complaint was not significant. Furthermore, had the plaintiff been persistently and vociferously complaining of pain up to that point, it would have been an obvious occasion to administer a more substantial dose from the 100mcg vial attached to her cannula. The decision to administer only a minor dose of fentanyl at that time tends to suggest that such complaints had likely not been made. Furthermore, the evidence suggests, that given that 75mcg of fentanyl remained in the vial after the infusion and that both Nurse Daly and Dr Kindler were alert to the issue of pain, it is inherently unlikely that they would not have followed it up with a further infusion if the plaintiff's alleged repeated protests and imploring had continued. This evidence taken in the round suggests that while the plaintiff did experience and express pain around 11.04am, it was relatively minor, occurred when some level of discomfort was to be expected, was managed with adequate and effective pain relief and was unlikely to have been preceded or followed by persistent crying and pleading.
136. As the plaintiff reported pain during the procedure and fentanyl was administered to manage it, it is agreed by the defendants' nursing expert that the plaintiff's pain ought to have been documented in the nursing notes which was not done. This omission constitutes a clear breach of duty on the part of the hospital, albeit a technical one and not a breach that was of itself causative of injury. It is a technical breach because Nurse Daly acknowledged that the administration of fentanyl inherently implies the presence of pain, even if it is not explicitly documented. It is nonetheless a breach that has deprived the court and the parties of a contemporaneous note which might have described the nature of the plaintiff's complaint and the demeanour of the plaintiff when she made it.
137. No nursing note was made of the plaintiff's response to the administration of fentanyl during the procedure. The absence of such a record has led to differing expert opinions on whether this omission constitutes a deviation from the standard of care. The nurse responsible for ensuring patient comfort and accurate documentation during the procedure was the circulating nurse, Nurse Daly. With no specific recollection of the procedure or the plaintiff, she gave evidence that after infusing fentanyl, her usual practice is to assess the effectiveness of the pain relief and inform the consultant if additional medication was needed. She explained that a note of the patient's response to the administration of fentanyl would not be made unless the pain was ongoing, or the fentanyl was ineffective, or if further infusions were required. This evidence aligns with the evidence given by the defendants' nursing expert, Nurse Perryman, their medical experts, Professor O'Neill and Dr O'Dwyer and the Plaintiff's anaesthetic expert, Dr Power, all of whom gave evidence to the effect that it is not standard practice to document something that did not happen and that only significant pain or notable events require documentation. This view was not shared by the Plaintiff's cardiological expert Dr Kurbaan who expressed the opinion that "good practice" requires documenting both the administration of fentanyl and its effects. Having reviewed the evidence on this issue, I am satisfied, for the reasons provided by the majority of the experts, that the mere absence of a record documenting the plaintiff's response to the administration of fentanyl does not of itself constitute a breach of duty.
138. Although she did not specifically address the issue just considered, the plaintiff's nursing expert gave evidence of her opinion that the hospital policies mandated the maintenance of an intraoperative pain chart, the absence of which she criticised as a breach by the hospital of its own policy. Nurse Kelly placed reliance on the hospital's policy titled 'Care of a patient for Insertion of an Intracardiac Device' which refers to "pain chart (form 52)" under the heading "Documentation". However, the document was never opened to me, leaving the issue of its relevance and application to the intraprocedural monitoring of pain unclear. Furthermore, in the same policy, under the heading "Intra operatively", a seemingly exhaustive list of intraoperative tasks is set out, a list that does not include the maintenance of an intraoperative pain chart. I am therefore of the view that there is insufficient evidence to show that the policy has any application to this case.
139. It is significant that, between the conclusion of the procedure at 11.35am and the plaintiff's return to the ward at 12.05am, she was observed crying on two separate occasions. There is a conflict of evidence regarding the extent to which the plaintiff was exhibiting emotional upset or distress. The plaintiff's evidence was that she was "really, really crying" during the procedure and crying "inconsolably" both at its conclusion and when she returned to the ward. This suggests that she was crying with sobbing and noticeable emotion during the procedure and crying with even greater intensity after the procedure was completed. Such crying is likely to have been accompanied by unmistakable audible cues and overt physical signs which would be difficult to miss and would likely have been documented had such crying occurred either during or after the procedure. Furthermore, given the need for the patient to remain still, it is highly improbable that the plaintiff was crying in such a manner during the procedure. The plaintiff further gave evidence of a verbal exchange with the member of the team who wiped her eye, suggesting that the staff member agreed with her that Dr Kindler ought to have stopped the procedure. This suggestion was never put to Clair Callinan in cross-examination and I make no finding in relation to it.
140. The evidence of Claire Callinan who interacted with her immediately after the conclusion of the procedure was that after removing the drape and while chatting with the plaintiff, as she and the nurses removed leads that had been attached to her, she noticed a tear in the plaintiff's eye for which she got a tissue. Claire Callinan interpreted this at the time as a sign of relief that the procedure had concluded, noting that such a reaction was not uncommon. She also said that she could not recall any verbal exchange with the plaintiff other than stating that she would have asked the plaintiff whether she was "okay" and would have involved the rest of the team, including Dr Kindler, if there was something that needed to be done. She said she did not report anything arising from her interaction with the plaintiff to Dr Kindler, thereby suggesting that the plaintiff was not voicing anything that would suggest distress or trauma. Although he did not interact with the plaintiff, Dr Kindler also gave evidence that as he was leaving the Cath Lab he observed her crying which surprised him but which he attributed to relief. Taken together, their evidence, which I accept in substance, tends to suggest that the plaintiff's presentation at the conclusion of the procedure was that of a patient who was mildly to moderately upset and tearful but whose demeanour was not such as to cause concern or alarm. Significantly, there was no suggestion made by any expert witness during the trial that her presentation immediately after the procedure was such that she required medical attention or pharmacological intervention by way of midazolam or otherwise. Her systolic blood pressure at the time was recorded at 175mmHg, a level more consistent with her ongoing anxiety during the procedure than with any sense of relief the plaintiff may have felt following its completion.
141. The defendants' nursing expert stated in answer to a question asked by the court that if the plaintiff was crying and not merely tearful, this ought to have been documented. While the evidence on this issue is finely balanced, I am satisfied that for the reasons given by Claire Callinan, whose evidence I accept, that her failure to record her observation that the plaintiff had a tear in her eye did not amount to a breach of duty. As there was no criticism by any medical or nursing expert of Dr Kindler's admitted failure to inquire of the plaintiff as to why she was crying and for how long, I make no finding as to its legal consequences.
142. Before being discharged onto the ward, the plaintiff was removed to the recovery suite where she was assessed for readiness for discharge from the recovery area. Following evaluation, she achieved a 9 out of 9 recovery score which indicated, among other things, that she was fully awake, talking, and well-oriented. There is no indication in the relevant record or in the nursing notes that she was crying, emotional or making any complaints during this assessment. The test was completed at 12pm before she was returned to the ward at 12.05pm.
143. The plaintiff gave evidence that upon her return to the ward she was crying inconsolably. However, out of seven subsequent recorded observations between 12.05pm and 5.40pm, only the first at 12.05pm suggests she was crying. The ward nurse, Nurse Linehan's entry in the nursing notes recorded that while the plaintiff was alert and oriented and denied pain, she was "emotional". Nurse Linehan in her evidence explained that the term "emotional" in this context suggested that the plaintiff was likely tearful or crying. She clarified that had her emotional state been "on the more moderate to severe level", she would have used stronger terms, such as "distressed" or "very upset" to describe her state, thereby suggesting that the plaintiff was less than moderately emotional. Nurse Linehan also stated that had the plaintiff appeared more distressed, she would have taken further steps to investigate, such as speaking with the plaintiff to understand the cause of her emotional reaction. It was not suggested in cross-examination that she ought to have made such enquiries. Although the plaintiff gave evidence of a verbal exchange with the ward nurse about the alleged inadequacy of sedation, this was never put to Nurse Linehan in cross-examination, and I make no finding in relation to it.
144. Between 12.15pm and 5.40pm there were six further observations recorded, five by Nurse Linehan and the last by Nurse Hickey, when her pain assessments were recorded, all showing no pain. At 5.25pm she was seen by Dr Lambert who examined her and found her fit for discharge. At 6pm the plaintiff was further assessed for discharge by Nurse Hickey who filled out a detailed questionnaire with the plaintiff's cooperation, gave her advice for postoperative care and dealt with any concerns or issues the plaintiff might have had. It is significant that the plaintiff's recorded response in the relevant Discharge Plan was that she had no concerns or issues. While the plaintiff suggests that she wanted to get out of the hospital as fast as she could, this evidence relating to the almost 6 hour period the plaintiff spent in hospital after last being observed crying at 12.05pm tends to suggest not only that she had ample opportunity to verbalise any complaints about pain, if she had cause to do so, but more importantly, that she did not do so. Nor is there anything documented to suggest that there was anything about her presentation during this period which caused concern or alarm on the part of the nurses and doctor with whom she interacted.
145. This contrasts with the plaintiff's demeanour as noted by her daughter Natasha with whom she spoke later that evening who described her mother as being very fragile, anxious, upset, disconnected, and broken.
Decision
146. Between the two conflicting accounts of the procedure, I prefer Dr Kindler's over that of the plaintiff, as it is not only more internally coherent and consistent but also better aligned with the general body of evidence in the case. Having carefully considered all the evidence in the round, I make the following findings of fact on the balance of probabilities:
(1) the anaesthesia and analgesia provided to the plaintiff were adequate and sufficient to prevent avoidable pain resulting from physical trauma;
(2) the plaintiff was actively monitored throughout the procedure by Nurse Daly;
(3) the plaintiff did not make repeated complaints of significant pain during the procedure;
(4) the plaintiff did make a complaint of pain at around 11.04am;
(5) the pain reported by the plaintiff was unavoidable despite adequate and effective anaesthesia and was promptly relieved by the titration of further local anaesthesia and the administration of 25mcgs of fentanyl;
(6) the fentanyl remained effective until around 11.14am, after which the likelihood of significant pain from physical trauma related to the procedure was minimal and remained so for the remainder of the procedure;
(7) the plaintiff did experience anxiety during the procedure, likely triggered by the pain she reported at approximately 11.04am and, likely further exacerbated and prolonged by an underlying susceptibility to anxiety of which Dr Kindler and the Cath Lab team were unaware;
(8) the onset of the plaintiff's anxiety was not caused by any act or omission of the defendants;
(9) The anxiety experienced by the plaintiff caused her to subjectively perceive some degree of trauma for an indeterminate period or periods during the procedure, but not at a level of pain that was excruciating or relentlessly so;
(10) the plaintiff did not report experiencing anxiety during the procedure;
(11) in the absence of any reported pain or anxiety, the plaintiff's elevated blood pressure, whether alone or in combination with her White Coat Hypertension, did not provide sufficient evidence to warrant or require the administration of midazolam;
(12) the plaintiff did not cry in an audible, intense and emotional way during the procedure, nor did she cry inconsolably at its conclusion or on the ward;
(13) the plaintiff did become tearful at some stage before the procedure concluded, with her level of distress and presentation likely to have been very similar to that observed by Clair Callinan at its conclusion;
(14) the duration for which the plaintiff was tearful before the conclusion of the procedure is unclear, but was likely more than minimal;
(15) the Cath Lab team were unaware of the fact that the plaintiff had a susceptibility to anxiety or that she was anxious or tearful during the procedure. It was only when the drape was removed that Clair Callinan observed that she was tearful and provided her with a tissue;
(16) the plaintiff's presentation at the conclusion of the procedure was that of a patient who was mildly to moderately upset and tearful, with no indication that her condition raised any clinical concerns that warranted medical attention or pharmacological intervention;
(17) after the procedure was completed, the plaintiff did not report experiencing any unaddressed pain during the procedure, nor did she, despite being asked about pain on seven occasions and having ample opportunity to do so, raise any complaints of pain at any time prior to her discharge from hospital at 6.20pm.
147. The sole potential issue of liability arising from these findings of fact is whether Dr Kindler, Nurse Daly or both, wrongfully failed to recognise that the plaintiff was tearful beneath the drape due to anxiety, despite her not disclosing her susceptibility to anxiety or voicing any complaints of anxiety or pain during the procedure. Even if this far from straightforward issue were to be resolved in the plaintiff's favour, a further and significant causation hurdle remains. Specifically, as to whether, had her tearfulness been noticed, and in light of the facts as found by this court, the plaintiff's likely presentation would have indicated anxiety or trauma severe enough to warrant pharmacological intervention at all, still less the administration of midazolam or any other drug, at a time and dosage that would likely have prevented the outcome of which the plaintiff now complains.
148. As is immediately apparent, the issue just identified does not arise from the plaintiff's evidence and is fundamentally different from the plaintiff's case as outlined in the Personal Injury Summons or in any of the five Notices of Further Particulars of Negligence that were served on behalf of the plaintiff. It is so far removed from the case that the defendants were prepared to meet that it cannot reasonably be said to be an issue of which the defendants had any notice or any opportunity to investigate, plead to, or interrogate in any meaningful way, particularly given that the plaintiff had denied any history of mental injury or psychological complaint in two Replies to Notices for Particulars. Furthermore, it is an issue that had not even been identified, still less addressed in any of the expert reports or in the evidence presented at trial such that its resolution in favour of the plaintiff can, at best, only be achieved by benevolent speculation on the part of the court, which is not permissible.
149. Even if it could properly be determined that the omission amounted to a breach of duty, it would be impossible to assess damages or to determine an award that is fair to all parties and proportionate, as required by law. This is because the quantum evidence provided by the plaintiff and her consultant psychiatrist is based on a narrative of extreme physical pain and gross neglect throughout the entirety of the procedure that diverges significantly from the facts as found by this court. As such, it offers no reliable basis for establishing that the defendants' actions caused the alleged or any psychiatric injury or harm. Awarding damages in such circumstances would violate the principle that compensation must be grounded in proven facts and a fair assessment of actual harm caused by the breach of duty.
150. For these reasons, I dismiss the claim.