Alrifai v Australian Capital Territory
[2022] ACTSC 48
SUPREME COURT OF THE AUSTRALIAN CAPITAL TERRITORY
Case Title: | Alrifai v Australian Capital Territory |
Citation: | [2022] ACTSC 48 |
Hearing Dates: | 21 – 25, 28 February, 1 March 2022 |
DecisionDate: | 18 March 2022 |
Before: | Balla AJ |
Decision: | 1. The plaintiff’s Application under rule 443(5) of the Court Procedures Rules 2006 is refused. 2. The evidence which was admitted provisionally, subject to determining the plaintiff’s Application under rule 443(5) of the Court Procedures Rules 2006, is now evidence in the proceedings. 3. Judgment for the defendant; 4. The plaintiff to pay the defendant’s costs. 5. Liberty to apply if any other costs orders are sought by either party. |
Catchwords: | NEGLIGENCE — Essentials of action for negligence — Medical negligence — Causation — Where plaintiff diagnosed with pancreatic cancer — Whether plaintiff would have undergone surgery earlier but for the alleged negligent acts relating to diagnosis — Whether earlier surgical intervention would have prevented injuries particularised |
Legislation Cited: | Civil Law (Wrongs) Act 2002 (ACT), ss 42, 43, 44, 45, 46 Court Procedures Rules 2006, r 443(5) |
Cases Cited: | Carton v Rainbow Plumbing & Drainage Pty Ltd [2013] ACTSC 267 Rogers v Whitaker (1992) 175 CLR 479; [1992] HCA 58 Tabet v Gett (2010) 240 CLR 537; [2010] HCA 12 |
Parties: | F Alrifai ( Plaintiff) Australian Capital Territory ( Defendant) |
Representation: | Counsel D Richards with L Edwards ( Plaintiff) V Thomas with K Beattie ( Defendant) |
| Solicitors United Legal ( Plaintiff) ACT Government Solicitor ( Defendant) | |
File Number(s): | SC 52 of 2021 |
Contents
Outline
The medical terms
Pancreatitis and pancreatic cancer
History
25 December 2017
Admission 1 to 3 January 2018
4 January to March 2018
Admission 6 to 10 April 2018
13 April to 2 May 2018
May to November 2018
The law
Causation
Factual Findings
Protocol
What do the CT scans show?
Causation – First limb
(a) Failure to identify increased risk
(b)(i) Differential diagnosis of pancreatic cancer
January 2018
April 2018
(b)(ii) PET scan and MR imaging
PET scanning
MRI
(d) Failing to perform an EUS earlier
(b)(v) MDT
(b)(iii)(iv) and (vi) Surgical opinion
January 2018
6 April 2018
26 April 2018
(c) Claustrophobia
(e) (f) (g) (h) Other
Other matters
Dr Subramaniam
Dr Drini
Scope of opinions
Finding – first limb
Causation – second limb
Prognosis and life expectancy
Risk of recurrence
Pain and suffering
Finding – second limb
Finding
Rule 443 of the Court Procedures Rules 2006
Orders
In December 2017 the plaintiff went to Canberra Hospital complaining of chest pain. After several admissions and a number of investigations she was diagnosed with pancreatic cancer in November 2018. In these proceedings she claims that the defendant, being the entity responsible for the Hospital, was negligent in failing to diagnose and treat the condition sooner.
Outline
The plaintiff relies on three key dates, in the alternative, as the times at which the Hospital was negligent:
(a) Immediately after a CT scan on 1 January 2018.
(b) Immediately after a CT scan on 6 April 2018.
(c) Immediately after a CT scan on 22 April 2018 and an endoscopic ultrasound (EUS) on 26 April 2018.
The plaintiff says that each of those CT scans showed a discrete mass in the pancreas and that finding was confirmed on the EUS. Because there was a mass, the Hospital should have obtained a surgical opinion. If this had been done, the tumour would have been removed earlier than 11 November 2018.
The Hospital admits that the failure to obtain a surgical opinion after 26 April 2018 was a breach of its duty of care to the plaintiff but denies that the breach caused any of the injury, loss or damage claimed by the plaintiff. The Hospital otherwise denies that it breached its duty of care to the plaintiff.
The witnesses
The plaintiff and her partner gave evidence.
Three treating doctors from the Hospital were called. All three, Dr Subramaniam, Dr Drini and Dr Aggarawal are gastroenterologists.
The plaintiff qualified three experts all of whom gave evidence. Professor Morris is a surgeon specialising in surgical oncology. Professor Fox is a retired haematologist and oncologist. Ms Stephenson is an occupational therapist.
The Hospital qualified four experts all of whom gave evidence. Professor Katelaris is a gastroenterologist. Dr Burge is an oncologist. Professor Richardson is a laparoscopic and general surgeon. Mr Rahme is an occupational therapist.
The medical terms
To be able to understand the history of the treatment of the plaintiff and the opinions of the experts I set out a brief explanation of some of the terms used in the proceedings.
A CA 19-9 blood test measures the amount of a protein called cancer antigen 19-9 in the blood. CA 19-9 is a type of tumour marker. Tumour markers are substances made by cancer cells or by normal cells in response to cancer in the body.
An EUS is an endoscopic ultrasound where an endoscope with an ultrasound probe at its tip, is inserted into the stomach and pictures are taken of the pancreas. During an EUS cells can be taken from the pancreas by a fine needle for biopsy (FNB).
An MDT is a multidisciplinary team of healthcare professionals from different fields who meet in order to determine a patient’s treatment plan.
An MRCP, which is Magnetic Resonance Cholangiopancreatography is a type of MRI scan used to evaluate the pancreas and pancreatic duct for disease.
Lipase is an enzyme made by the pancreas. It was the evidence of Professor Richardson that a blood test showing raised lipase is consistent with acute pancreatitis.
Pancreas divisum is a birth defect in which parts of the pancreas do not join together. Both Dr Aggarwal and Professor Richardson said pancreas divisum is a well-described cause of recurrent pancreatitis.
Pancreatitis and pancreatic cancer
Pancreatitis is an inflammation of the pancreas.
Acute pancreatitis is the most common presentation to the gastroenterology department of the Hospital.[1]
[1] Dr Aggarwal Transcript P 275
The two most common causes of pancreatitis are gallstones and alcohol, accounting for 80-90% of cases. [2]
[2] Professor Richardson Ex 2 P 102
There are many other rarer causes of acute pancreatitis including:
(a) Elevated serum triglycerides or cholesterol.
(b) Elevated serum calcium (eg hyperparathyroidism).
(c) Various medications including steroids, diuretics and chemotherapy.
(d) Infections by viruses or bacteria.
(e) A type of endoscopy, ERCP, has a risk of causing pancreatitis.
(f) Hereditary pancreatitis.
(g) Cystic fibrosis.
(h) lntraductal papillary mucinous tumours.
(i) Congenital causes such as pancreas divisum.
(j) Autoimmune pancreatitis.
(k) Pancreatic cancer which is the cause of 1% of cases of recurrent acute pancreatitis. The incidence of pancreatic cancer increases with age and more than 75% of cases are older than 55. In 2018 the plaintiff was 47.[3]
[3] Professor Richardson Ex 2 P 93
The size of the tumour defines the stage of the cancer. There are four stages. The T1 stage is divided into T1 a, b and c. A T1a tumour is less than 0.5cm, T1b is between 0.5cm and 1cm and T1c is between 1cm and 2cm. A T2 tumour is between 2cm and 4 cm.[4]
History
25 December 2017
[4] Professor Morris Ex B P 20
In the evening on 25 December 2017, the plaintiff presented to the Emergency Department (ED) at the Hospital. The discharge letter records that the plaintiff had central chest pain associated with shortness of breath and nausea. Blood tests and a chest X ray were done. Later that evening the plaintiff was discharged. The plaintiff was told that she possibly had gastro-oesophageal reflux disease or early pancreatitis[5].
[5] Ex 1 P 6
There is no claim against the Hospital in relation to this attendance.
Admission 1 to 3 January 2018
On 1 January 2018, the plaintiff was taken to the Hospital by ambulance complaining of left upper quadrant pain and left sided chest pain over the previous seven days.
The nursing assessment states:
"Six-day history of left-sided abdo pain radiating to back. Saw GP and taken analgesia and Maxolon. Seen in ED three days ago. Pain constant and taking regular Panadeine forte…”[6]
[6] Ex 1 P 46
In the morning on 1 January 2018 a chest x-ray was done. The findings were normal[7].
[7] Ex 1 P 26
In the afternoon, an abdominal CT scan was done. The report says:
"Findings:
There is some fat stranding surrounding the pancreatic body and tail with the pancreatic tail demonstrating slightly lower attenuation/oedema when compared to the remainder of the pancreas. Appearances are thought to relate to pancreatitis. No complication is identified…
Impression:
Features consistent with acute pancreatitis without complications.
No features to suggest diverticulitis.”[8]
[8] Ex C P 38 - 39
The plaintiff’s experts say that the area in the pancreatic tail described by the radiologist as “demonstrating slightly lower attenuation/oedema” should have been identified by the Hospital as a mass or a lesion from these images.[9] This is the first key date relied on by the plaintiff.
[9] Ex B P 62 (Professor Morris); Transcript P208 L33(Professor Fox)
The plaintiff was reviewed by Dr Frampton on 1 January 2018, after the results of the CT scan were available. Dr Frampton took a history and performed an examination. The doctor’s impression was mild pancreatitis with no adverse features and unclear aetiology. The plaintiff was admitted under the care of Dr Subramaniam[10].
[10] Ex 1 P 37 - 40
Dr Subramaniam first met the plaintiff when she conducted a ward round on 2 January 2018. She reviewed the CT images and report before she saw the plaintiff.
An abdominal ultrasound was performed on 3 January 2018[11]. The pancreas could not be seen well due to overlying bowel gas. The gallbladder was unremarkable with no evidence of gallstones which was important because it excluded the major cause of pancreatitis.
[11] Ex 1 P 25 - 26
Based on the clinical presentation of abdominal pain radiating to the back, the raised lipase of 188 and the imaging features suggestive of pancreatitis, Dr Subramaniam diagnosed acute pancreatitis. In relation to the cause of the pancreatitis, the ultrasound had excluded gallstones. Accordingly, she said, the next step was an MRCP to rule out other causes such as pancreatic divisum and to look for pancreatic lesions which could include both cystic lesions and tumours. Dr Subramaniam decided the plaintiff could have the MRCP done as an outpatient so the inflammation could settle before it was done, it was the holiday period so there were resource constraints and the plaintiff wanted to be discharged because she had just been told that her brother had died.
Dr Subramaniam said that, at the time, she was aware that pancreatic cancer is the cause of approximately 1% of pancreatitis but, at this early stage, her index of suspicion for pancreatic adenocarcinoma was very low.
The plaintiff was discharged on 3 January 2018 with a diagnosis of pancreatitis. The discharge letter to the general practitioner says:
"… she had features consistent with pancreatitis however no clear cause was identified…
Could you kindly arrange for her to have an MRCP prior to follow-up in February.
Follow-up results of MRCP with Dr Subramaniam's team in Clinic on 7 February 2018 at 0915.
Advised to return to hospital if severe pain returns.
Advised to avoid alcohol for at least 8 weeks.
Suggest GP follow-up within one week of discharge.
Could you kindly review Ms Alfirai's cardiac risk factors and consider commencing a statin on the basis of her cholesterol results (see below) and discuss options for quitting smoking."[12]
[12] Ex 1 P 22
The discharge letter was sent to the general practitioner by Healthlink.
4 January to March 2018
The plaintiff did not attend her general practitioner and did not attend her gastroenterology out-patient appointment with Dr Subramaniam on 7 February 2018. There is no evidence that the plaintiff attended for an MRCP in early February in accordance with the plan sent to her general practitioner.
At 1.30am on 26 February 2018, the plaintiff was brought to the Hospital by ambulance. The nursing assessment states:
"3/7 history of left flank pain”[13]
[13] Ex 1 P 761
About one hour after arrival, the plaintiff had an argument with a staff member over analgesia and left without seeing a doctor[14].
[14] Ex 1 P 761
Later that day, the plaintiff returned to the Hospital and was reviewed in the gastro-enterology outpatients department. The letter from Dr Angela Cropley, gastroenterology and hepatology registrar to the plaintiff’s general practitioner says:
"I reviewed Faten Alrifai in the Gastro clinic on 26 February.
She is a 46-year-old lady with a long standing history of abdominal pain that she ascribes to pancreatitis. She has had left flank and back pain; admitted in January briefly. There is no history of jaundice, no family history of pancreatitis, no weight-loss, no dysuria/haematuria. She has asthma, high cholesterol and has migraines. She takes Panadeine Forte and Nurofen Plus on a regular basis.
She is not unwell looking, but complaining of extreme pain. She is very keen on pain relief today reporting that the pain is ongoing.
I am unable to see that she is very unwell to require admission. I have given her a script for Targin.
We will need to just work out if there truly is any pancreas pathology so I have ordered an MRI scan for her and I will see her in the next few months in clinic again."[15]
[15] Ex 1 P 899
On 7 March 2018, the plaintiff was brought by ambulance to the Hospital. They took a two-day history of worsening left flank pain which radiated to the left upper quadrant and epigastric area associated with nausea and vomiting[16].
[16] Ex 1 P 78
The plaintiff was re-admitted under the gastroenterology team.
An abdominal ultrasound was performed 7 March 2018. The report says:
"Marked echogenic liver consistent with diffuse fatty infiltration.
The pancreas was not visualised due to bowel gas. No cholelithiasis was seen…”[17]
[17] Ex 1 P 85
A CT urogram was performed on 8 March 2018. The report says:
"Fatty stranding adjacent to swollen pancreatic tail. This corresponds to previously noted pancreatic abnormality on prior CT. ? acute pancreatitis and clinical/biochemical correlation is recommended.”[18]
[18] Ex 1 P 87
The MRCP requested by Dr Cropley on 26 February 2018 was attempted on 13 March 2018. However the plaintiff would not get into the machine because she has claustrophobia[19].
[19] Ex 1 P 134
Dr Subramaniam said it was then decided that the plaintiff would have the MRCP as an out patient, after taking some diazepam. In addition arrangements were made for the plaintiff to undergo an EUS at the Hospital.
The plaintiff was discharged on 13 March 2018. The discharge letter to the general practitioner says:
"Please note the following:
1. Faten will require an outpatient MRCP.
- Did not complete in-patient MRCP due to claustrophobia.
- Please prescribe oral diazepam as required for Faten to complete her MRCP.
2. Outpatient endoscopic ultrasound with Dr Aggarwal.
- Booked and consented.
3. Outpatient MRI thoracolumbar for radiculopathy.
- Booked.
4. Follow-up with Dr Subramaniam in gastro-enterology outpatient clinic after her MRI and MRCP scans.
5. We have advised Faten about the cessation of cigarette smoking. Please provide the appropriate supports and measures to assist in this.
6. Please chase her blood tests.”[20]
[20] Ex 1 P 79
The plaintiff was brought into the Hospital ED by ambulance on 19 March 2018. The letter to the general practitioner dated 20 March 2018 says:
"Faten presented to ED with left-sided chest pain which radiates down her left arm. She has a complicated history of pancreatitis with presenting symptoms similar. No history of ischaemic heart disease.
On examination, afebrile and stable, mildly tender over palpation of left subcostal region. Cardio-respiratory examination was unremarkable.
On investigation, chest Xray was clear. ECG shows normal sinus rhythm. Blood shows a white cell count of 13, neutrophils 7.3, lipase 79, 1st Troponin 28.
Patient decided to leave against medical advice. I've spoken to patient in detail regarding the risk of missing a NSTEMI[21] which consequence can be devastating, even fatal. I have also stated that if patient walks out the door we won't be responsible if her repeat troponin which were just sent shows a NSTEMI. Faten and her husband has decided to leave against medical advice after extensive conversation with me."[22]
Admission 6 to 10 April 2018
[21] A type of heart attack
[22] Ex 1 P 773
The plaintiff was brought by ambulance to the Hospital on 6 April 2018. The handwritten triage notes record that the plaintiff had a four day history of left upper quadrant abdominal pain, with a known history of pancreatitis and was awaiting MRI and MRCP. Her pain was similar to the pancreatitis pain radiating to her back and was associated with nausea, vomiting and constipation. A previous CT scan had shown fat stranding in the region of the pancreatic tail[23].
[23] Ex 1 P 189
The notes made by the ED consultant record on 6 April 2018 that the gastroenterology follow up plan was:
“MRCP – not yet done
EUS - ? booked for 31/5
MRI spine – not yet done
Clinic – to be booked post scans”[24]
[24] Ex 1 P 191
Later on 6 April 2018 Dr Wang, the advanced trainee on call, relevantly noted, after having discussed the plaintiff with Dr Drini:
“Plan
(1) Admit.
(2) CT pancreas protocol
CT thoracolumbar spine.
(given MR claustrophobia)”[25]
[25] Ex 1 P 195
The plaintiff was admitted under the care of Dr Drini.
An X ray of the abdomen on 6 April 2018 showed faecal loading but no conclusive evidence of a bowel obstruction[26].
[26] Ex 1 P 181
An abdominal CT scan was done the same day. The radiologist compared the findings to the CT scan on 1 January 2018. The report states:
"Findings:
… There is fat stranding surrounding the pancreatic tail which demonstrates low attenuation/oedema compatible remainder of the pancreas. Appearances are thought to relate to acute pancreatitis…
Impression:
Acute pancreatitis involving the pancreatic tail. The pancreatic tail demonstrates reduced enhancement/hypodensity that may reflect oedema or early necrosis (depending on the time interval between onset of symptoms and the current study). Repeat study is suggested to qualify the finding.
Attenuation/discontinuity of the splenic vein at the region of inflammation, suspicious for splenic vein thrombosis which is likely subacute in nature as there has been development of splenic varices."[27]
[27] Ex 1 P 182 - 183
The images of this CT scan are also evidence. The plaintiff’s experts say that the area in the pancreatic tail described by the radiologist as again demonstrating slightly lower attenuation/oedema should have been identified by the Hospital as a mass or a lesion from these images. Professor Morris says there is an abnormality.[28] This is the second key date relied on by the plaintiff.
[28] Ex B P 62
On 7 April 2018 the plaintiff was not at her bedside at the time of Dr Drini’s ward round that day.
On 8 April 2018 Dr Drini discussed the findings of the CT scan with the radiology registrar on call[29]. The findings consistent with splenic vein thrombosis could have been contributing to the pain. He then examined the plaintiff and found that her abdomen was soft but she was tender over the spine. It is recorded:
"Impression: Unlikely pancreatitis. ? spinal pathology."
[29] Ex 1 P 213; T P 412 - 413
After conducting a physical examination Dr Drini still suspected musculoskeletal nerve pain, which could potentially originate from the spine. The CT scan had ruled out major problems but an MRI would disclose whether there was any abnormality around the nerve that could refer the pain to the front of the abdomen or the left flank.
The Plan was, as recorded in the progress notes[30]:
(a) A rheumatology review, (which Dr Drini said was a specialised medical team) and MR of the spine with sedation.
(b) A gastroscopy and colonoscopy as an urgent category 1. Dr Drini said that this was because the X-ray had shown faecal loading and he wanted to exclude significant colonic pathology that could also cause pain.
(c) An increase in ‘Lyrica’, a pain modulating drug, which Dr Drini said is useful for nerve pain
(d) A physiotherapy review.
(e) An outpatient EUS and MR of the pancreas. Dr Drini said this was a reference to the plan already in place for the plaintiff to have an outpatient EUS and an MR to define the abnormalities seen in the tail of the pancreas.
[30] Ex 1 P 213
Dr Drini said that at the time he did not think pancreatitis was the cause of the plaintiff’s pain but it was not excluded and remained as a differential diagnosis because there remained some abnormality at the tail of the pancreas which needed to be further evaluated. Other possible causes of the pain, which he said was undifferentiated, needed further work-up.[31]
[31] Transcript P 415
Dr Drini said that at the time of the plaintiff’s discharge a request for an MRCP of the pancreas had been placed online, but the date was to be allocated by the radiology department.[32] This was explained to the plaintiff and her general practitioner in the discharge instructions[33].
[32] Transcript P 416
[33] Ex 1 P 176 - 177
The plaintiff was discharged on 10 April 2018.
13 April to 2 May 2018
The MRCP was done at the Hospital as an outpatient on 13 April 2018. The report says:
"Clinical history:
Pancreatitis with no clear cause.
The main pancreatic duct is not dilated measuring 2.5mm in diameter. It opens separately into the second part of the duodenum in keeping with pancreas divisum. The pancreatic head is drained by a separate duct which opens together with the CBD. No dilated intrahepatic biliary duct is seen. No gallstones or choledocholithiasis is seen. No peripancreatic fluid collection is seen.
Impression: Pancreas divisum"[34]
[34] Ex 1 P 874
On the same day an MR was done of the thoracolumbar spine. It did not show any evidence of traumatic injury[35].
[35] Ex 1 P 873
On 19 April 2018 the plaintiff went to the ED of the Hospital complaining of pain. She was admitted overnight for observation and analgesia[36].
[36] Ex 1 P 249
After the plaintiff was discharged, she went to see Dr Subramaniam in her private rooms. Dr Subramaniam told the treating general practitioner that:
“Today I have explained … the natural history of this pancreatitis …
Considering the findings of splenic vein thrombosis and the fact that there is ongoing inflammation it is quite hard to know whether this is thrombosis versus inflammation.” [37]
[37] Ex D P 1 - 2
As the plaintiff was in a lot of pain, Dr Subramaniam arranged for her to be admitted to the Hospital the next day for evaluation including an EUS.
The plaintiff was admitted to the Hospital on 21 April 2018 and discharged on 2 May 2018.
Dr Subramaniam consulted with a radiologist and a haematologist and the radiologist recommended a repeat CT scan.[38]
[38] Transcript P 315; see also Ex D P 1 - 2
The third abdominal CT scan was performed on 22 April 2018. The report states:
"Findings:
Comparison is made to the CT abdomen/pelvis dated 6/4/2018 and 1/1/18.
There is a hypoattenuating ovoid region within the tail of the pancreas, measuring 20 x 22 mm with areas of parenchymal enhancement and nonenhancement, pancreatic swelling, peripancreatic stranding and a small volume of free fluid, in keeping with pancreatitis and focal areas of pancreatic necrosis. There is no evidence of gas formation. The remaining pancreas demonstrates normal appearances and enhancement. Pancreas divisum is redemonstrated. The pancreatic duct is not dilated...
Impression:
1. Reduced ovoid enhancement and oedema involving the tail of the pancreas with associated surrounding fat-stranding and free fluid, in keeping with features of pancreatitis. Areas of non-enhancement within the pancreatic tail concerning for pancreatic necrosis.
2. Ongoing splenic vein thrombosis with associated varices. Considering local of inflammation in this region since January, an underlying pancreatic lesion cannot be excluded.
3. Stable appearances of hepatic steatosis."[39]
[39] Ex 1 P 875
The images of this CT scan are also evidence. The plaintiff’s experts say that the area in the pancreatic tail described by the radiologist as an hypoattenuating ovoid region should have been identified by the Hospital as a mass or a lesion from these images. Professor Morris says the “lesion is clearly visible”.[40]
[40] Ex B P 62
The plaintiff was reviewed on 23 April 2018 by Dr Subramanian. A stool sample was ordered, an EUS was arranged, tumour markers and genetic testing were ordered. The plaintiff was anticoagulated for her splenic vein thrombosis after advice from the haematology team.
On 24 April 2018 the results of the tumour marking testing recorded a CA19.9 of 31 which was within the normal range[41].
[41] Ex 1 P 877
Dr Subramaniam said at the end of April she had been very concerned that a cause for the plaintiff’s pancreatitis had not been identified, despite all of the tests which had been undertaken. She recommended to the plaintiff’s treating general practitioner that the plaintiff see Professor Jeremy Wilson at Liverpool Hospital whom she described as a leading and pre-eminent pancreatologist in Australia.[42]
[42] Ex 1 P 905
The EUS was performed on 26 April 2018. The report states:
''An irregular mass was identified in the pancreatic tail. The mass was heterogenous. The mass measured 20mm x 20mm in maximal cross-sectional diameter. The endosonographic borders were poorly defined. The remainder of the pancreas was examined. The endosonographic appearance of parenchyma and the upstream pancreatic duct indicated no ductal dilatation and no ductal abnormalities. Fine needle aspiration for cytology was performed. Three passes were made with the 25-gauge needle using a trans-gastric approach. A stilette was used. A cytologist was present and performed a preliminary cytological examination. The cellularity of the specimen was adequate. The final cytology results are pending…”[43]
[43] Ex 1 P 878a – 878b
The biopsy of the cells taken by fine needle aspirate from the tail of the pancreas during the EUS was reported on 26 April 2018 by Dr S Jain. This report states:
"Overall, the features are of acute pancreatitis with a small amount of cellular material showing worrying architectural and cytological changes.
However, in presence of inflammation, the atypia, at this stage, should be regarded as reactive in origin. Follow-up is recommended with review following resolution of the acute inflammatory process."[44]
[44] Ex 1 P 879
This is the third key date relied on by the plaintiff.
Dr Subramaniam said that because the EUS and FNB results were not conclusive she took them to an MDT on 1 May 2018[45]. Access to the imaging and pathology was provided to all of the participants before the meeting.[46]
[45] Referred to at Ex 1 P 327 and P 329; and Transcript P 318
[46] Transcript P 318
Dr Aggarwal did not remember the meeting but said he would usually have been present as the specialist who performed the EUS and the primary people who would definitely have been there were the referring physician (Dr Subramaniam), a radiologist and a cytopathologist.[47]
[47] Ex 1 P 286 - 287
Dr Subramaniam did remember the meeting. It had been attended by two radiologists, a pathologist, Dr Fadia, Dr Aggarwal and a number of other gastroenterologists. The radiologists and the gastroenterologists looked at the images. Dr Fadia reviewed the slides, went through the findings and told the meeting that the atypia should be considered as reactive. They then had a discussion and reached a consensus decision that this was an inflammatory process which needed ongoing follow up in the form of a repeat CT in three months. A pain management consultation was also requested for the plaintiff.[48]
[48] Ex 1 P 318
The discharge letter to the plaintiff’s general practitioner says:
"Primary Discharge Diagnosis:
Pancreatic tail pancreatitis
Additional diagnoses:
Chronic pancreatitis
Splenic vein thrombosis
Summary of management:
Admitted under gastro-enterology:
1. Pancreatic tail pancreatitis
- EUS
- Fine needle aspirate tail of pancreas – pancreatitis
- Pt refused to be NBM as advised by treating team and ate full diet throughout admission.
- Advised to stop smoking. However, refuses nicotine patch and frequently off ward.
- Faecal elastase test and PRSS1 done and will be followed up by Dr Kavitha Subramaniam.
- 3 months progress scan for pancreatic mass as an outpatient - CT ordered; patient will be contacted for an appointment date.
2. Splenic vein thrombosis
- Haematology input: advised to start Warfarin 5mg when patient is agreeable.
- Continue warfarin at adjusted dose (aim INR 2-3) for 6 months
- Re-image at 6 months
- If thrombosis resolved, then cease warfarin
- If thrombosis still present, please refer to haematology
- Thrombophilia screen (some results still pending)
- Script for clexane given. Patient to see GP to administer clexane and optimise IRN
3. Ongoing pain
- Patient frequently refuses regular pain relief medications
- Patient requested PCA on 28 April 2018 however went off ward for 5 hours and home team unable to organise with APS
- Referral will be made for chronic pain team review and patient will be contacted for appointment
- Script for pain relief given”[49]
[49] Ex 1 P 269 - 270
The plaintiff was asked to see her general practitioner within one week of discharge and an appointment was made for her to be reviewed in the gastroenterology outpatients by Dr Subramanian on 30 August 2018.[50]
May to November 2018
[50] Ex 1 P 270
On 9 May 2018, the plaintiff was brought to ED at the Hospital complaining of a sudden onset of left-sided chest and abdomen pain. Tests did not show any significant abnormality, she was treated with analgesia and antiemetics and advised to return to the Hospital if her pain worsened or if she experienced any infective symptoms.[51]
[51] Ex 1 P 794
On 29 May 2018 Dr Subramaniam performed a gastroscopy to assess for reflux. She found a small hiatus hernia, mild gastritis and duodenitis.[52]
[52] Ex 1 P 879a
On 14 June 2018, the plaintiff was brought to the Hospital by ambulance complaining of abdominal pain which had started earlier that day and nausea. She was given Fentanyl and Metoclopramide after which she was discharged because said she was pain free, wanted to leave and said she would come back if the pain worsened.[53]
[53] Ex 1 P 807 - 808
On 19 June 2018, the plaintiff presented to the Hospital with a sudden onset of chest and epigastric pain and was referred to the gastroenterology team. However, the plaintiff left before she was reviewed by the gastroenterology team.[54]
[54] Ex 1 P 410
On 22 June 2018, the plaintiff was seen by Dr Subramaniam in her private rooms. In the letter to the general practitioner, Dr Subramaniam said she was referring the plaintiff to Professor Jeremy Wilson, gastroenterologist, for his opinion.[55]
[55] Ex 1 P 913a
On 26 July 2018, a further EUS was performed by Dr Aggarwal. The plaintiff was being treated with anticoagulation medication, so it was not possible to perform a biopsy. The report relevantly says:
“Findings:
-An irregular mass was identified in the pancreatic tail. The mass was heterogenous. The mass measured 25mm by 20mm in maximal cross-sectional diameter. The endosonographic borders were poorlydefined. The remainder of the pancreas was examined. The remainder of the pancreas was unremarkable. No biopsies or other specimens were collected for this exam.
Impression:
-A mass was identified in the pancreatic tail. Tissue was not obtained. However, the endosonographic appearance is benign inflammatory changes although malignancy is not excluded on this examination. No specimens collected as patient is on warfarin .”
Dr Aggarwal recommended that the plaintiff have a CT scan in one week and see Dr Subramaniam in two weeks. If the CT showed a concerning mass a repeat EUS and FNB would be needed.[56]
[56] Ex 1 P 879 c
On 30 July 2018, the plaintiff underwent a contrast enhanced CT of the abdomen. The scan report says:
“Impression:
Features are suggestive of resolving pancreatitis involving pancreatic tail. Unchanged hypodensity within the pancreatic tail.
Persistent splenic vein thrombosis with multiple splenic and gastric varices.”
As I have said, Dr Subramaniam had referred the plaintiff to Professor Wilson. He first saw the plaintiff in Sydney on 7 August 2018. However he did not have access to all the imaging he needed to provide an opinion.[57]
[57] Ex 1 P 914
On 23 August 2018 the plaintiff presented to ED at the Hospital after having experienced a sudden onset of left sided chest pain. Blood tests and an ECG were done but the plaintiff declined to have an X ray. The plaintiff decided to leave, against medical advice, because she was asymptomatic.[58]
[58] Ex 1 P 819h
On 28 August 2018 Professor Wilson reported to Dr Subramaniam:
“This pleasant lady returned again this morning…
Since last seen, I have reviewed her films with the Department of Radiology here at Liverpool Hospital. Our impression of her CTs and MRCP is that the lesion in the tail of her pancreas seems to be resolving. Moreover, it looks more inflammatory than neoplastic.
…..
All other things being equal I think that Mrs Alrifai should undergo repeat imaging of her pancreas in late November/early December with review by me in December…..”[59]
[59] Ex 1 P 919
On 3 September 2018 the plaintiff presented to the ED at the Hospital with abdominal pain. The Hospital discharge summary relevantly says that the diagnosis was chronic pancreatitis and “Pt was meant to be admitted to National Capital today but refused for further tests. Pt contacted gastroenterologist who advised ED stay for analgesia and bed booked for tomorrow morning…Plan… Transfer to National Capital in the morning.”[60]
[60] Ex 1 P 438
The plaintiff was admitted to National Capital Private Hospital from 4 to 8 September 2018 under the care of Dr Subramaniam.[61]
[61] Ex 1 P 922 Ex C P165
On 23 September 2018 the plaintiff presented to the ED at the Hospital and told them she had her usual pancreatitis pain. She was given medication and observed and discharged the following day and asked to go her general practitioner in the next 7 days for review.[62]
[62] Ex 1 P 458 - 459
On 25 September 2018 the plaintiff presented to the ED at the Hospital with a sudden onset of severe left sided chest pain radiating to her back with shortness of breath.[63] A CT pulmonary angiogram, which was done to rule out a pulmonary embolism, was normal. The radiologist did report mild fat stranding adjacent to the pancreatic tail in keeping with recent pancreatitis.[64] The plaintiff was asked to see her cardiologist.
[63] Ex 1 P 829
[64] Ex 1 P 884
On 9 October 2018 the plaintiff presented to the ED at the Hospital with a sudden onset of severe left sided chest pain radiating to her back, similar to previous attacks in the past. She was admitted under the care of Dr Subramaniam. An abdominal ultrasound was performed and the plaintiff was discharged on 11 October 2018 with an instruction to see her general practitioner in the next seven days and attend her scheduled appointment at the outpatient gastroscopy department on 8 November 2018.[65]
[65] Ex 1 P 516 - 517
On 20 October 2018 the plaintiff presented to the ED at the Hospital with a history of two days of epigastric pain. The discharge letter notes her pain was typical for an exacerbation of pancreatitis. She was given opioids and a Fentanyl patch and discharged.[66]
[66] Ex 1 P845
On 29 October 2018 the plaintiff underwent a CT scan of the abdomen at the Hospital. The report relevantly notes:
“IMPRESSION:
Comparison to previous CT abdomen dated 30/7/18.
There has been no significant change in size of the hypoattenuating ovoid lesion in the pancreatic tail in comparison to the previous study dated 30/7/18. A mild decrease in density of this area is noted. The surrounding pancreatic fat stranding has also slightly improved appearance…
Chronic splenic vein thrombosis is redemonstrated…
IMPRESSION:
Evolutionary changes of pancreatitis within the pancreatic tail to previous CT abdomen dated 30/7/18. No underlying lesion has been demonstrated. MRI of the pancreas would be more definitive in excluding underlying lesion, if clinically suspected.”[67]
[67] Ex 1 P 888
On 8 November 2018, the plaintiff underwent a further EUS performed by Dr Aggarwal. It was reported that:
“Findings:
-An irregular mass was identified in the pancreatic tail. The mass was heterogenous. The mass measured 35mm by 40mm in maximal cross-sectional diameter. The endosonographic borders were poorly-defined. An intact interface was seen between the mass and the adjacent structures suggesting a lack of invasion. The remainder of the pancreas was examined. The endosonographic appearance of parenchyma and the upstream pancreatic duct indicated no duct dilation. Fine needle aspiration for cytology was performed…
Impression:
-A mass was identified in the pancreatic tail. Tissue was obtained from this exam and results are pending. However the endosonographic appearance is suspicious for adenocarcinoma.”[68]
[68] Ex 1 P 890
The FNB results were consistent with adenocarcinoma.[69]
[69] Ex 1 P 892
The plaintiff decided to be referred to a surgeon in Sydney. She was admitted to Royal Prince Alfred Hospital under Dr Gallagher's care from 26 November 2018 to 6 December 2018. On 26 November 2018 the plaintiff underwent a splenic artery angioembolism under interventional radiology. On 27 November 2018, a distal pancreatectomy and splenectomy were performed.
On 20 February 2019 FOLFIRINOX Modified Adjuvant chemotherapy commenced. The initial plan was to perform 12 cycles of the therapy. After the third cycle, on 10 April 2019, the therapy was ceased because of side effects. On 17 April 2019, an alternative, gemcitabine and capecitabine chemotherapy was commenced. In July 2019, it was ceased due to ongoing abdominal pain and nausea.
On 25 January 2021 a PET scan showed local recurrence of the cancer.
In February 2021, the plaintiff travelled to Germany to undertake liquid nitrogen therapy.
The plaintiff is currently receiving Larotrectinib 100mg twice daily.
The law
S 42 of the Civil Law (Wrongs) Act 2002 (ACT) (the Wrongs Act), sets the standard of care:
For deciding whether a person (the defendant) was negligent, the standard of care required of the defendant is that of a reasonable person in the defendant’s position who was in possession of all the information that the defendant either had, or ought reasonably to have had, at the time of the incident out of which the harm arose.
Both counsel agree and I accept that the section reflects the common law test which is that “the standard of reasonable care and skill required is that of the ordinary skilled person exercising and professing to have that special skill”.[70]
[70] Rogers v Whitaker (1992) 175 CLR 479; [1992] HCA 58 at 487
In the Further Amended Statement of Claim the plaintiff says that the Hospital breached its duty of care by:
(a) Failing to on or by 3 January or alternatively, 6 or 26 April 2018 recognise the increased risk of pancreatic adenocarcinoma given the combined symptoms of abdominal pain, pain in left-sided flank, upper abdominal tenderness, epigastric pain, nausea, vomiting, left-sided chest pain radiating down her arm and left upper quadrant pain, radiating to her back and umbilicus;
(b) Failing on or by 3 January or alternatively, 6 or 26 April 2018 to have:
(i) made or properly considered a differential diagnosis of pancreatic cancer.
(ii) conducted or ordered any PET and MR imaging combined with CT scanning.
(iii) discussed the plaintiff’s presentation with a surgeon at or immediately after those dates.
(iv) involved a surgeon in the care of the plaintiff at or immediately following any of those dates.
(v) discussed the plaintiff’s presentation in an appropriately credentialled MDT meeting at or immediately following any of those dates.
(vi) sought an opinion at or immediately following any of the latter attendances from a surgeon who could have explained to the plaintiff the pros and cons of further imaging or simply removing the mass following the results of the tests obtained in each of those respective times so as to exclude or detect the presence of pancreatic cancer.
(c) Failing in March 2018 to offer the plaintiff any treatment strategy to accommodate her fears as to claustrophobia in undergoing an MRI as recommended by the defendant including appropriate explanations, reassurance and as necessary, the implementation of appropriate sedative techniques involving use of intravenous agents such as Valium.
(d) Failing to perform an EUS at an earlier time in order to investigate or properly investigate the possibility of pancreatic cancer.
(e) Failing to properly diagnose the plaintiff with pancreatic adenocarcinoma at an earlier time.
(f) Failing to properly inform the plaintiff of the risks she faced in light of her signs and symptoms identified above;
(g) Failing to adequately or at all explain to the plaintiff the need for her to undergo further timely investigations and treatment in light of the signs and symptoms with which she had presented at the Hospital.
(h) Unreasonably making a diagnosis of pancreatitis following the EUS on 26 April 2018.
It is pleaded that in consequence of the Hospital's breach of its duty of care, the plaintiff lost the opportunity for a prompt diagnosis of pancreatic cancer on or shortly after 3 January 2018 (or alternatively, 6 or 26 April 2018) and was thereby deprived of the opportunity of being properly treated for that disease by the performance of a timely partial pancreatectomy which did not occur until November 2018.
In determining the issue of the liability of the Hospital it must be borne in mind that counsel for the plaintiff expressly, on more than one occasion, resiled from making any claim against the Hospital on the basis that any of the three radiologists who performed the CT scans were negligent.
Each of the particulars of negligence represents a “precaution” that, on the plaintiff’s case, should have been taken. The principles relevant to the assessment of those precautions are set out in s 43 of the Wrongs Act:
A person is not negligent in failing to take precautions against a risk of harm unless:
(1) A person is not negligent in failing to take precautions against a risk of harm unless—
(a) the risk was foreseeable (that is, it is a risk of which the person knew or ought to have known); and
(b) the risk was not insignificant; and
(c) in the circumstances, a reasonable person in the person’s position would have taken those precautions.
(2) In deciding whether a reasonable person would have taken precautions against a risk of harm, the court must consider the following (among other relevant things):
(a) the probability that the harm would happen if precautions were not taken;
(b) the likely seriousness of the harm;
(c) the burden of taking precautions to avoid the risk of harm;
(d) the social utility of the activity creating the risk of harm.
Section 44 of the Wrongs Act then relevantly provides:
(a) the burden of taking precautions to avoid a risk of harm includes the burden of taking precautions to avoid similar risks of harm for which the person may be responsible; and
(b) the fact that a risk of harm could have been avoided by doing something in a different way does not of itself give rise to or affect liability for the way in which it was done;…
The test for causation is set out in s 45 of the Wrongs Act:
(1) A decision that negligence caused particular harm comprises the following elements:
(a) that the negligence was a necessary condition of the happening of the harm (‘factual causation’);
(b) that it is appropriate for the scope of the negligent person’s liability to extend to the harm so caused (the scope of liability)…
(3) In deciding the scope of liability, the court must consider (among other relevant things) whether or not, and why, responsibility for the harm should be imposed on the negligent party.
Section 46 of the Wrongs Act provides:
In deciding liability for negligence, the plaintiff always bears the burden of proving, on the balance of probabilities, any fact relevant to the issue of causation.
Causation
I accept the submissions made by counsel for the defendant in relation to the manner in which the issue of causation in this case must be determined. The common law does not permit an action for recovery when the damage, for which compensation is awarded consequent upon breach of duty, is characterised as the loss of a chance of a better outcome[71]. This means that the plaintiff must prove, on the balance of probabilities:
[71] Tabet v Gett (2010) 240 CLR 537; [2010] HCA 12 at [46] (Gummow ACJ), [68] (Hayne and Bell JJ), [100] Crennan J and [152] Kiefel J.
(a) But for one or more of the alleged negligent acts or omissions, she would have undergone her surgery earlier than November 2018; and
(b) Had she undergone surgery at that earlier time, she probably would have avoided the injuries particularised in the pleadings.
Factual Findings
Protocol
As I have said pancreatitis is an inflammation of the pancreas. There are a number of causes. Investigations are performed to determine the cause of a patient’s pancreatitis.
Dr Subramaniam said it is her usual practice to perform all non invasive investigations and to obtain those results before organising invasive investigations such as an EUS which requires an anaesthetic.[72]
[72] Transcript P 308
Dr Aggarwal explained that investigation for the cause of a patient’s pancreatitis usually commences with the taking of a history and then non-invasive investigations such as blood tests and an ultrasound. If a cause is not clearly identified or if further information is sought, they would usually move on to a CT scan or a CAT scan, and, depending on what is found and the referring doctor's index of suspicion, the next step would be an MRI or MRCP. If at that stage a cause has not been ascertained, they would start to look at the rarer causes of pancreatitis such as auto immune pancreatitis with blood tests and gene studies. If none of those identify the cause some of the investigations may be repeated in case things have changed, most commonly a CAT scan is repeated.[73]
[73] Transcript P 276 - 277
Professor Katelaris said that usually an MRCP will be done to obtain the maximum amount of information before an EUS is done as it is invasive and carries a risk for the patient[74].
[74] Ex 2 P 5
I accept this evidence.
What do the CT scans show?
The words “mass”, “abnormality” and “lesion” have been used to describe an area in the pancreatic tail on the scans both by the reporting radiologists and the doctors giving evidence in these proceedings. The weight of the medical evidence is to the effect that these terms are not a diagnosis, but they mean that the appearance of the tissue is different to the surrounding area.[75]
[75] Transcript Pages 284 & 420
I accept that the weight of the medical evidence is to the effect that area of change in the pancreatic tail on the January and April 2018 scans is where the tumour was found in November 2018.
I will first determine whether I accept the opinion of Professors Morris and Fox in relation to the CT images.
To assist in understanding their opinions, I have repeated the relevant part of each report prepared by each of the radiologists together with the opinions of Professors Morris and Fox.
The first CT scan report says:
“1 January 2018
Dr Gaduguntla, radiologist
Findings:
There is some fat stranding surrounding the pancreatic body and tail with the pancreatic tail demonstrating slightly lower attenuation/oedema when compared to the remainder of the pancreas. Appearances are thought to relate to pancreatitis. No complication is identified…
Impression:
Features consistent with acute pancreatitis without complications.
No features to suggest diverticulitis.”[76]
[76] Ex 1 P 27
Professor Morris said in his last report dated 8 February 2022, after having seen the CT images of 1 January 2018, he could clearly see a mass in the tail of the pancreas.[77] He marked the mass with an arrow on the images attached to that report.[78]
[77] Ex B P 62
[78] Ex B P 64 - 67
Professor Morris had previously said in his first report dated 20 April 2021, that he had not seen the 1 January 2018 CT scan but had seen the report of the scan.
He concluded “In my opinion the plaintiff had a cancer of the tail of the pancreas as a cause for her presentation to the Hospital in January 2018. The initial investigations certainly weren’t diagnostic of this; I did not however find results for serum tumour markers which would be important”.[79]
[79] Ex B P 4 paras 20 and 21
In his next report dated 24 April 2021 Professor Morris said a CT diagnosis of a pancreatic mass always raises the possibility of malignancy and mandated appropriate investigation[80]. In this case it was very likely that a CA 19-9 tumour marker blood test would have alerted the clinicians to the real possibility of this being a cancer.[81] If that test had suggested the presence of cancer, surgery would have been indicated.[82] A surgeon would have understood the necessity of excluding a malignant cause for the pancreatic mass and after appropriate investigation it is very likely that the surgeon would have advised removal of the pancreas[83]. Those investigations would have taken a week, and the plaintiff would have been operated on in the public system within four weeks.[84]
[80] Ex B P 18 para 1a.
[81] Ex B P 19 para 1d.
[82] Ex B P 19 para 2
[83] Ex B P 19 para 2a.
[84] Ex B P 19 para 2b.
By the time Professor Morris prepared his third report dated 29 May 2021, he had been told that a serum tumour marker CA19.9 test on 24 April 2018 had been normal. He then said the test was not always reliable in detecting pancreatic cancer but it did not cause him to change his mind – the plaintiff had pancreatic cancer in December 2017 and an MRI should have been done. If an MRI had been done in January 2018 it was highly likely that a discrete mass in the pancreas would have been identified. If pancreatic cancer had been diagnosed in January 2018 she would have been a category 1 case which mandates surgery within four weeks.[85]
[85] Ex B P 50 - 51
In his fourth report dated 12 September 2018 Professor Morris said he had now reviewed the CT images which clearly demonstrated a mass in the tail of the pancreas.[86]
[86] Ex B P 55
In his last report, using a ruler, Professor Morris estimated a tumour diameter of just under 20mm.[87]
[87] Ex B P 62
Professor Fox said, after receiving the last report of Professor Morris, that he agreed that the arrow on the CT image is pointing to a clear cut hypodense lesion.
In his third report dated 31 May 2021, Professor Fox said that the decision to do an MRCP in January 2018 was evidence of a background consideration of pancreatic cancer. He considered it should have been done with the plaintiff sedated with Fentanyl and on the balance of probabilities it would have demonstrated pancreatic cancer.[88]
[88] Ex B P 136
The second CT scan report relevantly says:
“6 April 2018
Dr Dobes, radiologist
Findings:
There is fat stranding surrounding the pancreatic tail which demonstrates low attenuation/oedema compatible remainder of the pancreas. Appearances are thought to relate to acute pancreatitis…
Impression:
Acute pancreatitis involving the pancreatic tail. The pancreatic tail demonstrates reduced enhancement I hypodensity that may reflect oedema or early necrosis (depending on the time interval between onset of symptoms and the current study). Repeat study is suggested to qualify the finding.
Attenuation/discontinuity of the splenic vein at the region of inflammation, suspicious for splenic vein thrombosis which is likely subacute in nature as there has been development of splenic varices."[89]
[89] Ex 1 P 182 - 183
Professor Morris says that in reviewing the CT images of 6 April 2018, he can see an abnormality. He has again marked it with an arrow on the images attached to his report. He estimated a tumour diameter of just over 20mm[90].
[90] Ex 1 P 62, P 68 - 77
In his second report Professor Morris said that the changes on the CT were indicative of cancer. The most likely cause of the splenic vein thrombosis was pancreatic cancer and was a further reason, if one was needed, to investigate the plaintiff appropriately[91].
[91] Ex 1 P 19
The third CT scan report relevantly says:
“22 April 2018
Dr Harvey, radiologist
Findings:
Comparison is made to the CT abdomen/pelvis dated 6/4/2018 and 1/1/18.
There is a hypoattenuating ovoid region within the tail of the pancreas, measuring 20 x 200 mm with areas of parenchymal enhancement and nonenhancement, pancreatic swelling, peripancreatic stranding and a small volume of free fluid, in keeping with pancreatitis and focal areas of pancreatic necrosis. There is no evidence of gas formation. The remaining pancreas demonstrates normal appearances and enhancement. Pancreas divisum is redemonstrated. The pancreatic duct is not dilated...
Impression:
1. Reduce ovoid enhancement and oedema involving the tail of the pancreas with associated surrounding fat-stranding and free fluid, in keeping with features of pancreatitis. Areas of non-enhancement within the pancreatic tail concerning for pancreatic necrosis.
2. Ongoing splenic vein thrombosis with associated varices. Considering local of inflammation in this region since January, an underlying pancreatic lesion cannot be excluded.
3. Stable appearances of hepatic steatosis.”[92]
[92] Ex 1 P 875
Professor Morris says that, in these images, the lesion is again clearly visible and he has marked it with an arrow. He estimated a tumour diameter of just over 20mm.[93]
[93] Ex B P 62, P 78 – 93; 96 - 112
Only Professor Morris and Professor Fox can see an abnormality of such significance in the CT scans that a diagnosis of pancreatic cancer should have been made as early as January 2018 and certainly by April 2018.
Professor Morris also relies on that part of the EUS report done on 26 April 2018 which says "Overall, the features are of acute pancreatitis with a small amount of cellular material showing worrying architectural and cytological changes” as mandating the obtaining of a surgical opinion.[94]
[94] Ex B P 3 para 15
However, there is no evidence that any of the following doctors saw the “mass” “abnormality” or “lesion” seen by Professor Morris and Professor Fox on the CT images. They all were of the view that the changes were consistent with pancreatitis. Nor is there evidence from any of them accepting Professor Morris’ comments in relation to the EUS:
(a) The three radiologists who reported on the three CT scans. I have set out their reports with the relevant findings.
The evidence is to the effect that radiology is a highly specialised division of medicine with a very structured training program of about five years.[95]
[95] Dr Aggarwal Transcript P 282
As I have said, the plaintiff does not say that any of the three radiologists were negligent.
(b) The treating gastroenterologists, Dr Subramaniam and Dr Drini. Dr Subramaniam said she had reviewed the three CT scans and in general agreed with the radiologists’ reports[96]. Dr Drini said he did not consider the imaging showed an abnormality which required surgical intervention[97].
[96] T P 317
[97] T P 421
(c) The doctor who performed the EUS on 26 April 2018, Dr Aggarwal. Dr Aggarwal is a staff specialist gastroenterologist, interventional endoscopist and director of the gastroenterology and hepatology unit at the Hospital. Dr Aggarwal said that before the EUS he had viewed the investigations including the CT scans and his impression that they were most consistent with acute recurrent pancreatitis.
A tumour was always a differential diagnosis but the issue was to determine how high or low the possibility of a tumour was on the index of suspicion. In making this assessment he had taken into account that pain is an important feature of acute pancreatitis, but not a typical presentation of cancer.
The CT scan on 1 January 2018 had showed an area of abnormality compared to the rest of the pancreas.
The CT scan on 6 April 2018 had not altered the index of suspicion for pancreatic cancer because it showed a splenic vein thrombosis which is a clot within the splenic vein, seen much more commonly in acute pancreatitis or inflammatory conditions than pancreatic cancer.
The CT scan on 22 April 2018 had shown a 20 by 20 mm hypoattenuating ovoid region within the tail of the pancreas in a similar location. However the size of a lesion did not indicate that it was a cancer which was increasing in size, size can change due to other causes or aetiologies.
Dr Aggarwal concluded that the FNB on 26 April 2018 was also consistent with the existing index of suspicion. It showed inflammation, the possible causes of which were an inflammatory process or a cancerous process. The cytopathologist, who in this case was the most experienced cytopathologist in Canberra, made the call as to how confident he was as to the cause of the inflammation and he had concluded that it was reactive in origin not cancerous.
In the opinion of Dr Aggarwal, after the EUS, none of the investigations or the presentation of the plaintiff was consistent with a diagnosis of cancer although it still remained part of the differential diagnosis[98].
[98] T P 283 - 286
(d) The doctors at the MDT meeting on 1 May 2018[99]. I have already described the specialties of the doctors who attended at this meeting. As I have said, the consensus decision was that the investigations were consistent with an inflammatory process.
[99] Referred at Ex 1 P 327 and P 329
(e) Professor Wilson, a gastroenterologist, who provided a second opinion in August 2018, although exactly what material he sighted is not clear. However, I infer from his report that he had more than one CT scan and the MRCP because his report discloses, as I have said earlier, that he referred to the plaintiff’s CTs and MRCP. I am satisfied that the conclusion of Professor Wilson and the Department of Radiology at Liverpool Hospital is contrary to that of Professor Morris and Professor Fox when they concluded that those investigations were more consistent with the lesion in the tail of the pancreas resolving and looking more inflammatory than neoplastic (ie a tumour).
(f) Professor Richardson is a hepatic and pancreatic surgeon and deals with pancreatic cancer and pancreatitis virtually every day[100]. He viewed the images of the CT scans and described them as being of good quality and done in the portal venous phase which is specifically used to look for areas of necrosis or oedema in the pancreas[101].
[100] Transcript P 426 & 441
[101] Transcript P 433
In relation to the CT images on 1 January 2018, Professor Richardson said they showed areas of hypo or lower attenuation which are the areas which are a bit darker than the surrounding tissue. This is a usual finding with pancreatitis.[102] In addition the border of the pancreas was not as distinct as it normally would be which was consistent with oedema and swelling.[103]
[102] Transcript P 428
[103] Transcript P 429
In the opinion of Professor Richardson that CT scan was consistent with pancreatitis but he did not believe that you could with any confidence say that there was anything else going on in the pancreas[104]. He was confident that any pancreatic radiologist would say, 'This is acute pancreatitis and we can't tell much more than that at the moment.'[105]
In relation to the CT images on 6 April 2018, Professor Richardson did not agree with Professor Morris' opinion that there is a clearly visible mass on the images. In the opinion of Professor Richardson the images showed pancreatitis. Since 1 January 2018 the splenic vein had thrombosed which was consistent with acute pancreatitis. He agreed with the diagnosis that the radiologist had provided on 6 April 2018.[106]
In relation to the CT images on 22 April 2018, Professor Richardson did not agree with Professor Morris’ opinion that the lesion was clearly visible. He agreed with the radiologist that an underlying pancreatic lesion could not be excluded. Professor Richardson said that the appropriate next step was an EUS, which is what occurred.[107]
[104] Transcript P 434
[105] Transcript P 435
[106] Transcript P 438
[107] Transcript P 439
The first reason I do not accept the evidence of Professor Morris and Professor Fox as to what can be seen on the CT images is the overwhelming medical evidence to the contrary.
Secondly, as I have said, Professor Morris attached what he described as some of the images of the CT scans from 1 January, 6 April and 22 April 2018 to his report dated 8 February 2022. On each of those attachments he marked with an arrow where he says the mass is shown. However when Professor Richardson gave evidence the actual CT images were displayed to the Court[108]. They were obviously different – the attachments to the report of Professor Morris are black and yellow and the CT images are black and white. Professor Richardson thought Professor Morris probably screenshot the CT images and then printed them out.[109] This meant, he said, the attachments to the report did not have the same resolution as the scan the radiologist would have been looking at. I am satisfied that the area variously described by Professor Morris as a mass, abnormality and lesion which is shown on each of the attachments to the report (being the contrast between a grey/brown area and yellow background) is more obvious than the same area on the CT images. This impacts on the reliability of the reasoning of Professor Morris where he chooses to explain it by reference to those attachments.
[108] Transcript P 433
[109] Transcript P 433
Lastly, Professor Morris does not have any training in the reading of CT scan images. He said he looks at scans of the pancreas and other parts of the body every day, and like any specialist, has gained a great focussed knowledge in that area, which, he considers, a radiologist may not have. He does not however specialise in pancreatic surgery. He undertakes abdominal surgeries three to four times a week.[110] Despite Professor Morris’ confidence in his ability to detect pancreatic cancer on a CT scan, I take into account that doctors with specialised training in radiology (the radiologists) and a surgeon who specialises in hepatic and pancreatic surgery (Professor Richardson) do not agree with him.
[110] Transcript P 390
For these Reasons I do not accept the evidence of Professors Morris and Fox in relation to the three CT scans.
Causation – First limb
I will now consider the particulars set out in the Further Amended Statement of Claim. I have not dealt with them in the order set out in the pleading but have grouped together particulars which raise similar issues.
(a) Failure to identify increased risk
It is pleaded that the Hospital failed to, on or by 3 January, 6 or 26 April 2018, recognise the increased risk of pancreatic adenocarcinoma given the plaintiff’s symptoms.
Dr Subramaniam saw the plaintiff on 2 January 2018, after the CT scan, blood tests and liver function tests had been done. On the basis of the plaintiff’s clinical presentation of abdominal pain radiating to the back and the investigations, Dr Subramaniam formed an assessment that the plaintiff had acute pancreatitis[111]. The next step was to find the cause. One of the reasons she asked the plaintiff to have an MRCP was to look for pancreatic lesions which could include both cystic lesions and tumours[112].
[111] Transcript P 305
[112] Transcript P 306
I am satisfied that, after the plaintiff was diagnosed with acute pancreatitis in January 2018 based on her symptoms, investigations were commenced to ascertain the cause of the condition.
Professors Morris and Fox have not suggested that the diagnosis of pancreatic cancer should have been made in January or April 2018 solely by reason of the plaintiff’s symptoms, they say that the treating doctors failed to see evidence of a mass on the CT scans. I have not accepted this opinion.
This particular must fail.
(b)(i) Differential diagnosis of pancreatic cancer
It is pleaded that the Hospital failed to, on or by 3 January, 6 or 26 April 2018, make or consider a differential diagnosis of pancreatic cancer.
January 2018
Counsel for the plaintiff did not suggest there was any positive evidence establishing that the Hospital had failed to make a differential diagnosis of pancreatic cancer but asked me to view the evidence of Dr Subramaniam with caution. He relied on the evidence of Professor Morris, Professor Richardson and Professor Katelaris as support for the proposition that a CT diagnosis of a pancreatic mass should always raise the possibility of a malignancy.[113]
[113] Plaintiff’s submissions from para 5.11
As I have said, pancreatic cancer is one of the causes of pancreatitis.
I have accepted the evidence of Dr Subramaniam and found that that when the plaintiff was diagnosed with pancreatitis in January 2018 based on her symptoms, investigations were commenced to ascertain the cause of the condition. One of those possible causes was a tumour.[114] In this context, a differential diagnosis was pancreatic cancer. This evidence is consistent with evidence from many other sources.
[114] Transcript P 306
Both of the two other treating doctors at the Hospital said pancreatic cancer was part of the differential diagnosis.
Dr Drini said that, during the admission from 6 to 10 April 2018 his discharge diagnosis was chronic abdominal back pain of undetermined cause and constipation, but he knew there was some abnormality at the tail of the pancreas that he knew was being further evaluated and that pancreatic cancer definitely was a differential diagnosis[115].
[115] Transcript P 415 and Ex 1 P 191, 195 and 213
Dr Aggarwal said a tumour was always part of the differential diagnosis[116].
[116] Transcript P 282
In relation to the qualified doctors, Professor Fox said in his report dated 31 May 2021 that the request for the MRCP at an early stage together with the later tumour marker testing and repetitive scanning showed that the doctors were trying to determine the possibility of underlying pancreatic cancer associated with the plaintiff’s pancreatitis.[117]
[117] Ex B P 136
Professor Katelaris agreed with Professor Fox. He said that it was obvious from the records that the doctors involved were very aware of the possibility of an important secondary cause such as a tumour causing pancreatitis. That diagnosis was sought serially and repetitively with appropriate investigations. When those tests failed to show that cause, the doctors continued to arrange follow up despite negative tests, as is appropriate.[118]
April 2018
[118] Ex 2 P 9
There is no evidence that the Hospital abandoned the differential diagnosis of pancreatic cancer.
Dr Subramaniam did not say that she had, at any time, decided that pancreatic cancer was no longer a differential diagnosis.
The evidence of Dr Drini establishes that pancreatic cancer was still part of the differential diagnosis from 6 to 10 April 2018.[119]
[119] Transcript P 415
The evidence of Dr Aggarwal establishes it was still part of the differential diagnosis at the time of the EUS on 26 April 2018.
I decline to find that the plaintiff has shown that the Hospital failed on or by 3 January, 6 or 26 April 2018 to have made or properly considered a differential diagnosis of pancreatic cancer.
This particular must fail.
(b)(ii) PET scan and MR imaging
It is pleaded that the Hospital should have conducted:
(a) PET scanning; and
(b) MR imaging combined with CT scanning.
by 3 January or 6 or 22 April 2018.
PET scanning
It is common ground that a PET scan was not done before the plaintiff was diagnosed with pancreatic cancer.
In his report dated 23 April 2021, Professor Fox said it was likely that a PET scan would have revealed the tumour[120]. He repeated this in his later reports[121]. On cross examination Professor Fox agreed that there are differing views in relation to the benefit of PET scanning in the diagnosis of pancreatic cancer.[122]
[120] Ex B P120;
[121] Ex B P136 and P148
[122] T P 211
Professor Fox retired in 2006. When he was in practice before then, he was not involved in the management of patients up to the date of diagnosis of cancer other than attending at MDTs. In general he had not been involved in the decision making process leading to PET scans being performed[123].
[123] T P 203
I prefer the evidence of the other doctors who have commented on the appropriateness of a PET scan before the cancer diagnosis in November 2018. The effect of their evidence is that it is not used to diagnose cancer, as it cannot identify the cause of inflammation in the pancreas, but is used after diagnosis to see whether the cancer has spread.
Dr Subramaniam said that PET scans are not the imaging modality of choice for the diagnosis of pancreatitis. The presence of inflammation means the test would be positive so that it would not have any added benefit or value[124].
[124] T P 307
Dr Drini said a PET scan is inappropriate as it would confuse the clinical scenario because any abnormalities highlighted could be caused by inflammation. It is usually used to look for secondary malignancies[125].
[125] T P 417
Dr Aggarwal said a PET scan is not a very useful modality in differentiating acute pancreatitis from either chronic pancreatitis or pancreatic cancer because it does not usefully differentiate inflammation from cancer[126].
[126] T P 278
Professor Richardson said in his report dated 16 October 2021 that he could not disagree more strongly with Professor Fox’s statement and later described it as nonsense. An FDG-PET scan was contraindicated because there would be uptake on the scan due to the inflammation. There was likely to be a false positive. A PET scan in 2018 was not indicated as part of the routine diagnosis or staging of a patient with pancreatic cancer. The National Comprehensive Cancer Network guidelines from 2015 do not include PET scanning as part of the recommended investigation pathway for a suspected pancreatic cancer.[127].
[127] Ex 2 P 149 - 150
Dr Burge agreed that PET scans can be useful in staging pancreatic adenocarcinomas once a diagnosis has been made and referred to a paper he had authored on the topic. He said that the role of PET scanning in making the diagnosis of pancreas adenocarcinoma in the setting of pancreatic masses/lesions is uncertain and this is reflected in the latest version of the guidelines from the National Comprehensive Cancer Network.[128]
[128] Ex 2 P 36
Professor Morris agreed with Professor Richardson that a PET scan is often not much use in differentiating cancer from pancreatitis unless there is evidence of disease outside the pancreas[129].
[129] Ex B P 58
I decline to find that the plaintiff has shown that the Hospital should have conducted PET scanning on or by 3 January or 6 or 26 April 2018.
MRI
The second part of this particular pleads a failure to conduct MRI imaging combined with CT scanning on or by 3 January or 6 or 26 April 2018.
Professor Morris is of the view that it is highly likely that an MRI in January 2018 would have demonstrated the pancreatic cancer[130].
[130] Ex B P 51
As I have already set out, Dr Subramaniam had already decided an MRI was necessary before the plaintiff was discharged from the Hospital on 3 January 2018. On discharge the plaintiff was asked to attend for an MRCP as an outpatient before her next appointment with Dr Subramaniam on 7 February 2018. Her general practitioner was sent a copy of the discharge letter. There is no evidence that the plaintiff attended for the MRCP.
The investigation was rearranged for 13 March 2018 but could not proceed because the plaintiff felt claustrophobic.
Professor Katelaris said it is usual practice to wait a few weeks after a CT scan to allow the inflammation to settle and improve the likelihood of identifying the underlying problem[131].
[131] Transcript P 340 – 341 and 346
When the MRCP was done on 13 April 2018 it did not, to use the words of Professor Morris, demonstrate the pancreatic cancer.
I decline to find that the plaintiff has shown that the MRCP should have been done earlier than it was done. If I am wrong, I find that the plaintiff has not shown that this would have altered the course of the investigation and treatment of the plaintiff up to 26 April 2018.
I decline to find that the plaintiff has established particular (b) (ii).
(d) Failing to perform an EUS earlier
It is pleaded that the Hospital should have performed an EUS at an earlier time to properly investigate the possibility of pancreatic cancer.
I have already accepted that there is a protocol for the investigation of the cause of a case of acute pancreatitis which starts with non-invasive investigations first, after which, if a cause has not been found, an EUS, which is an invasive investigation.
The role of an EUS is not necessarily to define how the pancreas looks but to obtain tissue samples for histological testing[132].
[132] Transcript P 277
Professor Katelaris was of the opinion that the management provided to the plaintiff was consistent with standards expected of a tertiary teaching hospital[133].
[133] Ex 2 P 10
Similarly Professor Richardson was of the view that, based on his review of the clinical records, the plaintiff was appropriately investigated and managed[134].
[134] Ex 2 P 105
I decline to find that the plaintiff has shown that the EUS should have been done earlier.
(b)(v) MDT
It is pleaded that the Hospital failed to discuss the plaintiff’s presentation in an appropriately credentialed MDT meeting at or immediately after 3 January, 6 or 26 April 2018.
I was not taken to any evidence to support the proposition that there should have been an MDT at or immediately after 3 January 2018. Dr Drini said they are held after investigations have been completed[135]. I accept this evidence. I decline to find that the plaintiff has shown that the Hospital should have arranged an MDT at or immediately after 3 January 2018.
[135] T P 417
Professor Morris said in his report dated 20 April 2021 that, after the EUS on 26 April 2018, it would have been mandatory to discuss the plaintiff’s case in an appropriately credentialed MDT meeting[136].
[136] Ex B P 3
Consistently with the opinion of Professor Morris, an MDT meeting did take place on 1 May 2018, five days after the EUS.
The only remaining issue is whether the MDT was appropriately credentialed.
In the opinion of Professor Morris a clinical pathologist, the radiologists who had reviewed the imaging, the interventional endoscopist who had performed the EUS, a surgeon and an oncologist should have attended the MDT.[137]
[137] T P 381
In fact all of these specialists did attend, other than a surgeon and an oncologist. In circumstances where a diagnosis of cancer had not been made it is unclear to me what the role of the oncologist would have been. I have found elsewhere in these Reasons that a reasonably competent surgeon would not have seen a mass of the type identified by Professor Morris in the three CT scans. Assuming that these two additional specialists had attended at the MDT I decline to find that the plaintiff has shown it would have affected the outcome of the MDT or made any difference to her management.
This particular must fail.
(b)(iii)(iv) and (vi) Surgical opinion
It is pleaded that, at around 3 January or 6 or 26 April 2018, the Hospital should have discussed the plaintiff’s presentation with a surgeon, involved a surgeon in her care and sought an opinion from a surgeon who could have explained to her the pros and cons of further imaging or simply removing the mass.
January 2018
Dr Subramaniam said that on 2 January 2018 she did not think there were any indications for referral to a surgeon. Gallstones had been excluded. They were waiting on a number of investigation results and the results of the MRCP which was to be organised by the general practitioner.
Professor Katelaris has practised as a gastroenterologist for 34 years. He is a senior staff specialist in gastroenterology at Concord Hospital. Professor Katelaris was of the view that the plaintiff had been managed by an appropriate medical specialist with expertise in the management of pancreatitis to 26 April 2018. He did not believe that the plaintiff would have been investigated differently if a surgeon had been involved in that period.[138] He strongly disagreed with Professor Morris’s opinion that if a surgeon had been involved, the mass would have been removed shortly after 3 January 2018. He said he did not think any reasonable surgeon would approve of that course, it did not accord with peer practice and he hoped Professor Morris would not operate without a diagnosis as diagnosis generally precedes major life-threatening surgery[139].
[138] Ex 2 P 105
[139] Transcript P 343
I did not understand Professor Morris to ultimately say that a diagnosis of cancer could be made on the basis of the 1 January 2018 CT scan alone but rather that a surgeon should have become involved and the surgeon would have, within five or so weeks, diagnosed a tumour requiring removal after investigations had been undertaken and have operated to remove it.
In relation to the investigations which that surgeon would have ordered, there is no clear evidence as to which tests Professor Morris was suggesting should have been undertaken after the 1 January 2018 CT scan which would have led to a diagnosis of cancer in January or February 2018.
As I have already said, Professor Morris initially suggested it was likely that a CA 19-9 tumour marker blood test would have alerted the clinicians to the real possibility of this being a cancer and surgery would have been indicated. When he found out that the test had been done and the result was negative, he was of the opinion that an MRI should have been done and if it had been done in January 2018 it was highly likely that a discrete mass in the pancreas would have been identified. The MRCP was done in April 2018 and I have made findings in relation to it under particular (b) (ii).
Firstly I am not persuaded that the plaintiff has shown that a surgical opinion should have been obtained in January 2018.
Secondly there is no evidence before me from which I could conclude that the involvement of a surgeon in January 2018 would have meant a different course would have been pursued in the investigation and management of the plaintiff’s condition up to April 2018.
Even if I had found that the CT scan on 1 January 2018 had shown a suspicious mass, I am satisfied that Professor Morris and Professor Fox do not have the relevant expertise to give evidence as to what reasonable doctors in the position of Dr Subramaniam and Dr Drini should have done.
At some hospitals, including the Canberra Hospital, patients with pancreatitis are treated by the gastroenterology team, whether as inpatients or outpatients. Other hospitals admit these patients under the surgical teams.[140] The plaintiff was admitted on four occasions between 1 January and 2 May 2018. The first two and the final admission were under Dr Subramaniam. The third admission was under Dr Drini. They are both gastroenterologists.
[140] Dr Aggarwal Transcript P 276
Neither Professor Morris nor Professor Fox is a gastroenterologist.
Professor Morris is a surgeon specializing in surgical oncology. He operates on a very wide range of organs and conditions in the abdomen three or four times a week and frequently removes tumours which involve the pancreas. He is not an accredited radiologist but said he looks at scans of the pancreas and other parts of the body every day, and has a focussed knowledge in that area, which a radiologist may not have.
Professor Fox practised as an oncologist until he retired in 2006. Professor Fox was not involved in the management of patients up to the date of diagnosis of cancer.
Professor Katelaris is a gastroenterologist. I infer from his reports that he did not view the CT images. However, he was provided with the Hospital records and generally agreed with the course of treatment of the plaintiff up to the end April 2018.
I have already referred to the decision of the High Court in Rogers v Whitaker where it was held that the standard of reasonable care and skill required is that of the ordinary skilled person exercising and professing to have that special skill. In those proceedings the appellant in the High Court was an ophthalmic surgeon. The Court held that the conduct of the appellant was to be determined reference to “the skill of an ophthalmic surgeon specializing in corneal and anterior segment surgery.”[141]
[141] At para [6]
Applying that principle to these proceedings, the plaintiff must show that the treating gastroenterologist ought reasonably to have come to the same opinions as the plaintiff’s doctors as to what was shown on the CT scans on 1 January 2018 and involved a surgeon in the care of the plaintiff at that time who would have operated on the plaintiff earlier. Professor Morris and Professor are not gastroenterologists. There is accordingly no such evidence.
6 April 2018
As I have already said, Dr Drini said that during the admission from 6 to 10 April 2018 he did not consider the imaging showed an abnormality which required surgical intervention.[142]
[142] T P 421
During this admission, a CT scan was undertaken, an EUS was booked and, by the time of the plaintiff’s discharge from the Hospital, an outpatient MRI had been organised.
I am satisfied that this is consistent with the evidence of Dr Katelaris and Professor Richardson who said the treating team moved through the appropriate investigations to evaluate the pancreatitis and to assess for the presence or absence of a tumour.
I decline to find that the plaintiff has shown that the Hospital should have sought a surgical opinion around 6 April 2018 in circumstances where the cause of the pancreatitis was still being investigated.
Further, for reasons I will set out in relation to the failure to obtain a surgical opinion after 26 April 2018, I decline to find that the plaintiff has shown that a surgical consultation in early April 2018 would have altered the course of investigation and treatment of the plaintiff.
26 April 2018
The Hospital has conceded that a surgical opinion should have been obtained after the EUS on 26 April 2018 which showed “worrying architectural and cytological changes”. This is in accordance with the opinion of Professor Richardson.[143]
[143] Ex 2 Page 104 Para 70
The issue that then arises is whether this would have made any difference to the course of treatment afforded to the plaintiff.
Dr Aggarwal said that usually pancreatitis is managed by a gastroenterologist or physician and when there is an indication for a surgical opinion a surgical opinion is obtained. But that does not imply that the management of the patient would have been any different[144].
[144] T P 297
In determining whether the plaintiff has shown that, if a surgical opinion had been obtained on 26 April 2018, she would have undergone surgery earlier than November 2018, I take the following findings into account:
(a) Professor Morris’ interpretation of the CT images underpins his opinion that surgery should have been performed immediately after 26 April 2018. I have not accepted that opinion. I also decline to find that a reasonably competent surgeon would have seen a mass which needed immediate removal in the investigations done up to 26 April 2018 for the same reasons I have not accepted the opinion of Professor Morris, the primary reason being the overwhelming medical evidence to the contrary.
(b) I infer that, if a surgeon had become involved on 26 April 2018, he or she would have attended the MDT on 1 May 2018. As I have said the specialists at that meeting arrived at a consensus that the findings of the FNA were likely an inflammatory response. There is no basis for me to conclude that the surgeon would have dissented from that consensus, after listening to the other doctors.
(c) In cross examination, Professor Morris gave evidence of the information he would have provided to the plaintiff before the operation to obtain informed consent, where imaging demonstrated the presence of a mass, but there was no positive cytology:
(i) The risk of time passing while the mass was being investigated if it turned out to be malignant;
(ii) The risks of the surgery, including haemorrhage, thromboembolic disease and pancreatic tail fistula and anaesthetic risks;
(iii) The risk that the lesion was benign and that the resection was unnecessary.
(iv) The removal of the spleen, which would require the patient to take medication for the rest of their lives.
(v) The risk of death from the procedure, although Professor Morris regarded it as small.[145]
[145] Transcript P 378 - 381
There is no evidence from the plaintiff as to what she would have done if, after 26 April 2018, she had been offered surgery and been given this information.
(d) In his report dated 24 April 2021 Professor Morris said that after the EUS on 26 April 2018 “A surgical opinion was required, who could have explained to Ms Alrifai the pros and cons of further imaging or simply removing the mass.”[146]
[146] Ex B P 20
In relation to the alternative of carrying out further imaging rather than surgery, in cross examination Professor Morris added:
“At the very least, I would have recommended that further imaging, further biopsies, further scans were required because one really only has a limited opportunity to help people with this and the earliest opportunity is their best opportunity.[147]
Professor Morris agreed that inflammation can confound CT imaging results and that suspected inflammation is a consideration that would need to be taken into account in determining the timing of the imaging.[148]
I accept the submission made by counsel for the defendant that this evidence from Professor Morris of the further steps which “at the very least” were needed before surgery is consistent with the further investigations that were planned on the plaintiff’s discharge from the Hospital on 2 May 2018.
[147] Transcript P 383
[148] Transcript P 383
I decline to find that the plaintiff has shown that, if a surgical opinion had been obtained on 26 April 2018, she would have undergone surgery earlier than November 2018.
I decline to find that the plaintiff has established particulars (b) (iii), (iv) and (vi).
(c) Claustrophobia
It is pleaded that the Hospital failed, in March 2018, to offer the plaintiff any treatment strategy to accommodate her fears as to claustrophobia including appropriate explanations, reassurance and sedative techniques using intravenous agents such as Valium.
As I have said, on 13 March 2018 the Hospital had arranged for the plaintiff to have an MRCP. It did not occur because the plaintiff found the equipment too claustrophobic.
Professor Morris said in his report dated 29 May 2021:
“… even when she was admitted in March 2018 it was not done because of claustrophobia. It should have been. Ms Alrifai should have been sedated or even anesthetised”.[149]
[149] Ex B P 51 Para 4
Professor Fox suggested that the plaintiff should have been given a sedative agent such as Valium.[150]
[150] Ex B P 120 Para 3
Dr Subramaniam said that, at the time, the radiology department would have contacted the junior medical officers to administer a sedative. Any delay would have impacted on the other patients booked for an MRCP so the MRCP was rescheduled with a plan for a medical officer to be present to provide sedation. It did take place on 13 April 2021.
I assume that the plaintiff is asserting that the plaintiff should have been sedated on 13 March 2018 so that the MRCP could have been done on that day. Why that did not occur has been explained. There is no evidence to the contrary.
In any event, when the MRCP was performed on 13 April 2018, it did not identify any pancreatic mass, but suggested pancreatic divisum which is a cause of acute pancreatitis. I decline to find that an earlier MRCP would have altered the management of the plaintiff.
I decline to find that the plaintiff has established this particular.
(e) (f) (g) (h) Other
It is pleaded that the Hospital:
(e) Failed to diagnose the plaintiff with pancreatic adenocarcinoma earlier;
(f) Failed to properly inform the plaintiff of the risks she faced in light of her signs and symptoms;
(g) Failed to adequately or at all explain the need for her to undergo further timely investigations and treatment in light of her signs and symptoms;
(h) Unreasonably made a diagnosis of pancreatitis following the EUS.
Insofar as these particulars depend on my accepting the opinion of Professor Morris, they must fail.
Particulars (e) and (h) are a restatement of the plaintiff’s case and do not raise any new issues.
In relation to particulars (f) and (g), the plaintiff said no one from the Hospital told her before 11 November 2018 that she possibly had pancreatic cancer.[151] If she had known how serious her condition was, she would not have discharged herself from the Hospital.[152]
[151] Transcript P 40 & 42
[152] Transcript P 43
I prefer the evidence of Dr Subramaniam which is supported by the clinical notes. Dr Subramaniam said she took a family medical history of cancer on 9 March 2018 and, at that time, told the plaintiff they were undertaking tests to exclude cancer.[153]
[153] Transcript P 311; Ex 1 P125
I decline to find that the plaintiff has established any of these particulars.
Other matters
Dr Subramaniam
Counsel for the plaintiff submitted that Dr Subramaniam had no genuine recollection of having reviewed the CT scan images and radiology report of 1 January 2018 before her review of the plaintiff on 2 January 2018 and had only given evidence of her usual practice. I was invited to find Dr Subramanian did not look at the CT scan on 2 January 2018, particularly given that her evidence was that her practice was to look at the scans, unless it was busy[154].
[154] Plaintiff’s submissions Para 5.21
This submission misstates the evidence Dr Subramaniam gave while being cross examined by counsel for the plaintiff:
“I just want to clarify that issue. You are aware if it was not – as I understand your evidence, if it was not too busy you would have looked at the records before the consultation?---Yes, correct. I always look at the records. When I say time permit is how much time we put in looking at every record and every image on a CT scan but before seeing anyone I always look at the presentation up to that point.”[155]
Dr Drini
[155] Transcript P 324
Counsel for the plaintiff submitted that Dr Drini’s diagnosis of back pain and constipation was not correct and was a breach of duty of care by the Hospital as it led to further delays in the Hospital making a diagnosis[156].
[156] Plaintiff’s submissions Paras 5.22 – 5.24
It is true that Professor Richardson said he did not accept that the plaintiff was suffering from anything other than pancreatitis at that stage and could not really understand why anybody though she had spinal pathology.[157]
[157] Transcript P 443
As I have already recounted, Dr Drini said he ordered investigations to exclude a back condition as the cause of the plaintiff’s pain, in circumstances where he was aware there was a plan in place for investigations ordered by other doctors to define the abnormalities in the tail of pancreas.
In these circumstances I decline to find that this led to any delay in diagnosis.
Scope of opinions
Counsel for the plaintiff submitted that Dr Burge, Dr Katelaris and Professor Richardson were not asked by the Hospital to provide an opinion on whether a diagnosis should have been reasonably made after April 2018 while Professor Morris and Professor Fox were strongly of the view that a diagnosis should have been made as early as January 2018, but certainly by April 2018.
Counsel for the plaintiff submitted that as the Hospital’s expert witnesses did not provide an opinion on diagnosis after April 2018, and as both Professor Morris and Professor Fox opined that a diagnosis should have been made by April 2018, the only evidence before the Court is that a diagnosis of pancreatic cancer should have been made by April 2018.
For the Reasons set out earlier, I am satisfied that the defendant’s experts engaged directly with the plaintiff’s experts as to the consequences of the investigations done up to and including the EUS on 26 April 2018 as set out in the pleadings.
I do not accept this submission.
Finding – first limb
I decline to find that the plaintiff has shown that, but for one or more of the alleged negligent acts or omissions, she would have undergone her surgery earlier than November 2018.
Causation – second limb
The next issue is whether, if the plaintiff had undergone surgery earlier, she would probably have avoided the injuries particularised in the pleadings.
In the Further Amended Statement of Claim the plaintiff says:
“26.In consequence of the defendant's breach of its duty of care to the plaintiff and negligence above the plaintiff lost the opportunity for a prompt diagnosis of pancreatic cancer on or shortly after 3 January 2018 (or alternatively, 6th or 26th April 2018) and was thereby deprived of the opportunity of being or properly treated for that disease by the performance of a timely partial pancreatectomy which did not occur until November 2018.
PARTICULARS OF LOSS/DAMAGE
The breach of duty of the defendant caused or contributed to cause the plaintiff injury, loss and damage.
(a) Pancreatic adenocarcinoma
(b) Need for extensive and ongoing medical management.
(c) Need for care
(d) Loss of income
(e) Loss of normal life expectancy.
(f) Alternatively, to subpara (e) above loss of likelihood of survival of the order of 5 years.
(g) In further alternative to subparas (e) & (f) loss of likelihood of survival of 5 years or more.
(h) Emotional distress
(i) Pain and suffering
(j) Need for analgesia to manage cancer pain.
(k) Loss of amenities of life
(1) Loss of enjoyment of life
(m) Requirement for palliative care
(n) Interference with the enjoyment of sexual relations”
In the Amended Statement of Particulars the plaintiff says:
“1.1The plaintiff suffered personal injury because of the medical negligence of the agents and servants of the Canberra Hospital. The failure to detect and treat a pancreatic cancer has resulted in her imminent death.
1.2Dr Jain, her treating oncologist, has recently suggested that her life expectancy is now in the order of 18 months having previously made a more pessimistic prognosis. He attributes that improved life expectancy to the successful trial of the recently approved drug Vitrakvi (100mg). Vitrakvi is not a cure. It will simply delay the inevitable.
1.3… But for the failure identified in paragraph 1.1 above, the plaintiff would likely have been treated successfully and lived a full and normal life. Her life expectancy but for the recurrent pancreatic cancer was in the order of a further 36.8 years.
1.4The plaintiff is a mother of 7 children and grandmother to 5 grandchildren. The family unit is a close-knit group. The plaintiff is now deprived of having the opportunity of seeing her grandchildren grow up.
1.5The plaintiff faces the daily spectre of her imminent demise. She is in excruciating and constant physical pain which is only controlled by morphine. She describes the mental anguish of the prospect of not being around for her children and grandchildren as her greatest.
1.6She has difficulty sleeping because of the pain. She is constantly lethargic because of her medications. She struggles to eat and keep food down. She is essentially housebound save for attendances on specialists for treatment.
1.7There have been more than 40 attendances at the Canberra Hospital from the end of 2017 to the date of the commencement of proceedings. The plaintiff describes being treated by the Canberra Hospital like a hypochondriac at times and at others like a drug addict looking for pain relief for unjustified reasons.”
Of course I have previously found that the plaintiff has not shown that the mass should have been removed at around 1 January or 6 or 26 April 2018. Accordingly it is not necessary for me to determine the second limb of causation.
I set out below the findings I would have made in relation to the second limb if there had been a finding that the plaintiff had shown the mass should have been removed earlier than 11 November 2018.
Prognosis and life expectancy
It is likely, on the whole of the evidence, the mass did grow between 1 January and 11 November 2018.
On the measurements made by Professor Morris, the mass was at stage T1c in January 2018 and T2 at both 6 and 26 April 2018. It was still at stage T2 when it was removed in November 2018. Professor Fox was unsure of the staging definitions and said he would have to go back and look at the tables.[158]
[158] Transcript P 222
There is competing evidence from two oncologists, Professor Fox and Dr Burge as to the consequences.
I prefer the evidence of Dr Burge to that of Professor Fox and Professor Morris for the following reasons:
(a) Dr Burge is a medical oncologist who subspecialises in gastrointestinal medical oncology. He treats many patients with pancreatic ductal adenocarcinoma of all stages in his clinics[159]. Accordingly his expertise is directly relevant to the issues of prognosis and life expectancy to be determined by me. Professor Fox has not had any relevant clinical experience in treating patients with any form of cancer since 2006. Before that, he was not a specialist in pancreatic cancer.[160]
[159] Ex 2 P 75 - 76
[160] Transcript P 216
(b) Professor Fox and Professor Morris relied on a study[161] which considered the prognosis of pancreatic cancer determined by tumour location.
[161] Ex 2 P 749; Meng et al “Disparities in survival by stage after surgery between pancreatic head and body/tail in patients with nonmetastatic pancreatic cancer BMC Gastroenterology (2019) 19:59.
Professor Fox said the study was reliable because it used the SEER database, which he described as enormous, covering 1/3 of the population of the United States[162].
[162] Transcript P 251
Dr Burge pointed out that the study had many flaws as outlined by the authors in the discussion section of the paper. For example, the study had started looking at outcomes for patients in the years before adjuvant chemotherapy had been used. This means that the effect of adjuvant chemotherapy, which has made a difference, had not been captured. In addition the authors did not know how patients had been treated after they had surgery.[163]
[163] Transcript P 359 – 360; Ex 2 P 10 of the paper Meng et al (supra) commencing on P 749
Professor Fox did not think this was a problem. He said that all authors have to record the limitations and no study is absolutely perfect. It was reliable, he said, because of the large sample size.[164]
I do not accept this evidence from Professor Fox. Relying on a study to form an opinion about prognosis which has not allowed for the effects of chemotherapy is not persuasive in circumstances where there are other studies.
Dr Burge, in forming his opinion, relied on a meta-analysis of 93 studies[165] which he said demonstrated that, if there is any difference between the prognosis depending on tumour location, it is very small and could very well be contrary to the conclusions in the paper referred to by Professor Fox. As a consequence of this meta-analysis, when pancreatic research teams are designing clinical trials, tumour location is not taken into account. The pancreatic cancer community does not proceed on the basis that there is any significant relationship between tumour location and prognosis.[166]
[164] Transcript P 251
[165] Tomasello et al 'Outcome of head compared to body and tail pancreatic cancer: a systematic review and meta-analysis of 93 studies' Journal of Gastroenterology 2019; 10(2) 259 - 269
[166] Transcript P 357
I am satisfied that Dr Burge has significantly more expertise that Professor Fox as to current issues in pancreatic oncology. I prefer his evidence to that of Professor Fox where they conflict.
I accept the opinion of Dr Burge that:
(a) It is not likely that the plaintiff would have avoided a terminal diagnosis if her pancreatic cancer had been diagnosed in April 2018 rather than November 2018. Pancreatic adenocarcinoma carries a dismal prognosis and the vast majority of people who are diagnosed with the disease, die from it. While relative survival rates have modestly improved over the past 20-30 years and are better for younger patients, nonetheless similar annual incidence and death rates are seen from the disease in Australia[167].
[167] Ex 2 P 34
(b) Both Professors Morris and Fox relied on a change in the tumour size from January to November 2018 to infer that the prognosis must have been worse.
Dr Burge said it is reasonable to assume the tumour did grow over that time. However the conclusion of Professors Morris and Fox was flawed as they had failed to consider the enormous biologic complexity of pancreatic adenocarcinoma, the interplay of various prognostic markers including nodal stage and microscopic resection margins and the cancer’s ability to metastasize early. Most, but not all, studies do find that pathologic tumour size is prognostic for survival, after resection. This association reflects the biology of the cancer and its metastatic potential, amongst other unknown factors. It is far too simplistic to conclude that patients with larger tumours have a poorer survival simply because they were diagnosed later. Tumour size is just one of many prognostic factors that reflect cancer biology and impact patient outcomes[168].
[168] Ex 2 P 35 and P 76
The proof that adjuvant FOLFIRINOX chemotherapy markedly improves prognosis comes from a large, randomized trial. In that study, tumour size was not associated with disease free survival.[169]
[169] Ex 2 P 35
(c) The modern treatment approach for localized pancreatic adenocarcinoma is multi-disciplinary and involves both surgery and combination chemotherapy. It is becoming increasingly common to defer surgery and use pre-operative chemotherapy (sometimes with radiotherapy). Most patients managed by Dr Burge’s group who are diagnosed with pancreatic adenocarcinoma are not treated with immediate surgery. They are given 3 - 6 months of pre-operative chemotherapy in part as a test of time to better select patients for surgery. Results from a randomized trial of pre-operative chemoradiation versus immediate surgery and adjuvant chemotherapy from Europe has demonstrated that despite lower rates of surgery in the group treated with pre-operative chemoradiation (hence deferred surgery), the survival of that patient group was superior. [170]
[170] Ex 2 P 35
(d) Dr Burge did not agree with Professor Fox who had said that if the plaintiff had been diagnosed with pancreatic cancer in January 2018 she would have undergone a partial pancreptectomy and possibly adjuvant chemotherapy and that, given the small tumour size at that time, it is likely she would have avoided a terminal diagnosis. Dr Burge said that the plaintiff still had pancreatic adenocarcinoma in January 2018, and the prognosis for pancreatic adenocarcinoma is poor.[171]
(e) In addition, Dr Burge said, the plaintiff has a unique, and rare, molecular subtype of pancreatic adenocarcinoma. The cancer harbours an NTRK fusion oncogene, which is driving the malignancy. This subtype represents only 1 in 250 - 300 cases of pancreas adenocarcinoma. Most pancreas adenocarcinomas (>90%) are driven by KRAS mutations, which is not seen in this case. Therefore, with such unique biology, he could not be certain of the impact of surgery or adjuvant chemotherapy on prognosis as there is no data looking at this very rare subtype. This clouded his ability to state with any certainty what impact earlier treatment may have had[172].
(f) If the plaintiff’s pancreatic cancer had been diagnosed and treated earlier in 2018 (including in January 2018) it is not likely that she would have avoided adjuvant chemotherapy because it is routinely used after surgery for pancreatic adenocarcinoma, regardless of stage, as all patients are considered to be at sufficiently high risk of recurrence to warrant chemotherapy[173].
[171] Ex 2 P 35
[172] Ex 2 P 36
[173] Ex 2 P 77
I decline to find that the plaintiff has shown that if the mass had been removed in January or April 2018 it would have affected the prognosis of her condition or her life expectancy.
Risk of recurrence
I have not accepted the evidence of Professors Morris and Fox.
I have accepted the evidence of Dr Burge. I decline to find to find that the plaintiff has shown that an earlier operation would have reduced the risk of recurrence of her pancreatic adenocarcinoma.
Pain and suffering
Professor Morris said that the same procedure would have been done, including the removal of the spleen, regardless of when the operation had taken place[174].
[174] Transcript P 380
I have accepted the opinion of Dr Burge. As I have already said, Dr Burge said that the plaintiff would have undergone chemotherapy treatment regardless of when the operation had taken place.
Accordingly the pain and suffering from the operation and the chemotherapy would not have been avoided if the operation had been done earlier.
Without recounting all of the evidence relating to the plaintiff’s treatment since surgery in November 2018, I accept the submission made by counsel for the defendant that, unfortunately, the plaintiff has continued to experience frequent bouts of severe abdominal pain.
Counsel for the defendant submitted and counsel for the plaintiff did not dispute that:
(a) The plaintiff had approximately 10 presentations to ED for abdominal or epigastric pain in 2018. A number of these presentations resulted in admissions.
(b) The plaintiff was brought in by ambulance to ED for acute attacks of abdominal or epigastric pain approximately 48 times in 2019.
(c) The plaintiff was brought in by ambulance to ED for acute attacks of abdominal or epigastric pain approximately 73 times in 2020.
(d) The plaintiff was brought in by ambulance to ED for acute attacks of abdominal or epigastric pain approximately 32 times in 2021.[175]
[175] Defendant’s submissions para 176
Counsel for the defendant identified the various diagnoses for the plaintiff’s ongoing chronic abdominal pain in the plaintiff’s clinical records as follows:
(a) Likely post-surgical rather than disease progression related.
(b) Pain hard to classify as the plaintiff’s disease is currently not progressive.
(c) Multifactorial like post-surgical, cancer recurrence and chronic pancreatitis.
(d) Worsening due to significant psychosocial stresses/complex personal and emotional history.
(e) No obvious cause found/cause uncertain/cause unexplained.
(f) Onset with adjuvant chemotherapy post distal partial pancreatectomy.
(g) Possibly post-operative nerve damage.
(h) Persistent post-surgical pain which has been heightened on a background of peripheral sensitisation.
(i) Chronic pancreatitis.
(j) Superficial nerve damage.
(k) Pancreatic cyst.[176]
[176] Defendant’s submissions para 177
A review at the Palliative Care unit of the Hospital on 16 November 2021 noted that the plaintiff’s attacks were being controlled by medication and concludes “She (the plaintiff) is aware that the most likely reason for this pain is post surgical rather than disease progression related”.
If it had been necessary for me to decide, I would have declined to find that a delayed operation had caused the plaintiff’s ongoing epigastric and abdominal pain.
Finding – second limb
I decline to find that the plaintiff has shown that earlier surgery would, on the balance of probabilities, avoided any of the injuries she claims in the Further Amended Statement of Claim and the Amended Statement of Particulars.
Finding
For these reasons the plaintiff’s claim must fail.
Rule 443 of the Court Procedures Rules 2006
At the commencement of the hearing the plaintiff made an Application under rule 443(5) of the Court Procedures Rules 2006.
That Rule relevantly says:
(2) The defendant must, in the defence, specifically admit or deny every material allegation of fact in the originating claim and statement of claim, including by way of particulars.
…
(5) If the defendant wishes to prove a version of facts different from that alleged in the originating claim or statement of claim, the defendant must plead that version in the defence.
The Defence does say that the plaintiff discharged herself against medical advice on 25 December 2017. The plaintiff objects to any other attempt by the Hospital to refer to any similar conduct because it is not pleaded.
I do not accept the proposition that the Hospital leading evidence of the plaintiff’s conduct which is set out in the medical records can be characterised, in this case, as being a different version of the facts to those set out in the plaintiff’s pleadings.
In Carton v Rainbow Plumbing & Drainage Pty Ltd [2013] ACTSC 267 the Court held:
“71. The purpose of this additional obligation is to reduce the potential for defendants to ambush a plaintiff with an alternative version of what occurred based on a mere denial in a defence. It is, therefore, a rule entirely consistent with the purpose of chapter 2 of the Court Procedures Rules set out in rule 21. It means that unless a defendant positively pleads its alternative version it will not be entitled to establish, through cross-examination in the plaintiff’s case or in its own case a version of facts different from that alleged in the originating claim.
72. The rule will have its broadest operation where the plaintiff pleads the circumstances of the accident in greater rather than lesser detail. Where that occurs, the defendant will be obliged to be specific in putting forward its different version of the facts. If a plaintiff pleads in generalities then there will be more potential for a defendant to remain consistent with sub rule (5) while making general denials or pleading limited facts in its defence.”
I decline the Application for four reasons.
Firstly I do consider that the plaintiff has referred to the facts in lesser rather than greater detail, to use the terminology set out in that decision. The facts are set out in just over three pages. The details of each attendance at the Hospital are sparse.
Secondly I do not accept that the Hospital has used the plaintiff’s conduct as a “different version of events” in the sense that an alternative scenario is being presented. For example, in paragraph 4 of the Further Amended Statement of Claim the plaintiff has asserted that she was admitted to the Hospital on 1 January 2018 for two days and was investigated and treated. Paragraph 5 then deals with her next attendance on 26 January 2018. The Hospital wishes to lead evidence of the plaintiff being asked on discharge on 3 January 2018 to have an MRCP as an outpatient before 7 February 2018 in circumstances where there is no evidence of the plaintiff having done so. I do not consider that this is a different version of the same event.
Thirdly, I take into account that this is the conduct of the plaintiff herself, not of a witness unknown to the plaintiff. This means that there is no relevant “ambush” of the plaintiff with this evidence.
Lastly, I consider that it is essential for me to be able to make accurate findings as to the sequence of events in 2018 to be able to determine whether there was any relevant delay.
Orders
I make the following Orders:
(1) The plaintiff’s Application under rule 443(5) of the Court Procedures Rules 2006 is refused.
(2) The evidence which was admitted provisionally, subject to determining the plaintiff’s Application under rule 443(5) of the Court Procedures Rules 2006, is now evidence in the proceedings.
(3) Judgment for the defendant.
(4) The plaintiff to pay the defendant’s costs.
(5) Liberty to apply if any other costs orders are sought by either party.
| I certify that the preceding two hundred and eighty-nine [289] numbered paragraphs are a true copy of the Reasons for Judgment of her Honour Acting Justice Balla Associate: Date: 18 March 2022 |
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