CORONERS ACT, 1975 AS AMENDED

1. INTRODUCTION 2

2. HAEMOLYTIC URAEMIC SYNDROME 6

(a) Explanation 6

(b) Treatment 9

3. THE DEATH OF NIKKI ROBINSON 10

(a) Background 10

(b) First symptoms 10

(c) The Lyell McEwin Hospital 13

(d) Connection with Garibaldi 14

(e) Back to Lyell McEwin Hospital 16

(f) The Womens and Childrens Hospital 18

(g) Cause of Death 19

4. OTHER CHILDREN DIAGNOSED WITH HUS 22

Cases 1 - 23

5. OTHER PATIENTS 43

6. BACKGROUND - PREVIOUS INFORMATION AVAILABLE 50

(a) The Tibaldi Outbreak - 1982 50

(b) The Gallichio wedding - 1991 50

(c) The Pisani outbreak 54

(d) Dr. Andrews' research 56

(e) Codes of Practice and Legislation 61

(f) Conclusion

7. THE MANUFACTURING PROCESS 65

(a) Source meats 65

(b) Mettwurst production 73

(c) Use of starter culture 75

(d) Monitoring of pH levels 78

(e) Industry practice 80

(f) Standard operating procedures 81

(g) Water activity monitoring 81

(h) Pasteurisation 82

(i) The maturation process 83

(j) General hygiene issues 86

(k) Reworking 87

(l) Repacking 89

8. THE EPIDEMIOLOGICAL INVESTIGATION 90

(a) What is an epidemic? 90

(b) Responsibility for the investigation 91

(c) Chronology 92

(d) Connection with Garibaldi 95

(e) Effectiveness of investigation 96

(i) Knowledge of the disease 96

(ii) Knowledge of the product 97

(iii) Methodology 97

(iv) Development of Questionnaire 98

(v) Parent interviews 99

(vi) Analysis of data 100

(f) Notifiable Diseases 102

(g) The McAnaulty Review 105

(h) Conclusion 107

9. THE MICROBIOLOGICAL INVESTIGATION 108

(a) Techniques adopted 108

(b) The initial tests 111

(c) The connection with Garibaldi 112

(d) Further testing 113

(e) Conclusion 114

10. THE RECALL PROCESS 115

(a) The Ministerial Announcement 115

(b) The Voluntary Recall 117

(c) No mention of Salami 119

(d) The powers of the SA Health Commission 122

(e) Further Ministerial announcement? 125

(f) Publication in languages other than English? 125

(g) Other Issues arising from the Recall Process 126

(h) Conclusions

11. CHANGES TO LEGISLATION 128

12. ENFORCEMENT 131

(a) Conclusion 134

13. RECOMMENDATIONS 136

1. INTRODUCTION

At about 8.10a.m. on Wednesday 1 February 1995 Nikki Robinson died in her mother's arms. She had been admitted to the Womens and Childrens Hospital ("WCH") at about noon on Monday 30 January 1995, having been transferred from the Lyell McEwin Hospital at Elizabeth. Just prior to her transfer, a diagnosis had been made that she was suffering from Haemolytic Uraemic Syndrome (HUS).

Nikki was the fourteenth in a total of 23 children who were diagnosed as suffering from HUS during an epidemic which took place in South Australia during January and early February of this year. Apart from one child who was treated interstate, all of those children were admitted to the WCH and 20 of them required dialysis for varying periods.

Apart from the tragic death of Nikki, at least five of the other children suffered lasting symptoms which have been attributed to the condition and, although it is difficult to predict with certainty, several of them may well suffer permanent and significant disabilities as a result.

As such, the epidemic constituted a major health crisis in this State and has given rise to many questions concerning the manufacture and distribution of food, particularly meat products, the sufficiency and effectiveness of enforcement of legislation and regulations concerning same, and the efficiency and effectiveness of epidemiological and diagnostic techniques in relation to food-borne illness.

In addition to the 23 children I have already mentioned, approximately 150 other people contracted illness of varying degrees of severity and many of those illnesses were suspected of being associated with the epidemic.

The first clear case reported to the South Australian Health Commission ("SAHC") involving a child was that of Michelle Vanderkop, aged six months. Her case was reported on 4 January 1995. She had been admitted to the WCH on 26 December 1994, and underwent dialysis for a period of eleven days.

The second case was that of Joshua Sadler, aged three years, which was reported to SAHC on 16 January 1995. He had been admitted to the WCH on 14 January 1995 and underwent dialysis for a total of nine days. The third case of Timothy Faulkner, aged three years, was also notified to SAHC on 16 January 1995. He had been admitted to the WCH late in the afternoon of 14 January 1995.

By the time the second and third cases were reported to SAHC on 16 January 1995, a picture was emerging that an epidemic was about to take place. Thereafter, reports arrived at SAHC in rapid succession, until the 23rd case, Jasmine Munn-McDonnell, aged three years, was admitted to the WCH on 19 February 1995.

These successive admissions to hospital set in train several investigations into the cause of the epidemic. These investigations occurred in parallel, and each involved a race against time to establish the cause of the illness quickly enough to minimise the number of people at risk. These investigations included:-

· a microbiological investigation into the identification of the organism responsible for the illness and its mode of transmission. This principally involved the microbiologists attached to the WCH, and at the Institute of Medical & Veterinary Science ("IMVS"), who were involved in testing faecal specimens taken from the affected children, and the testing of food samples collected by the SAHC;

 

· an epidemiological investigation by officers of the Public and Environmental Health Service, a division of SAHC. This investigation involved interviews with the families of the patients, in an attempt to identify common factors associated with the patients, and the collection of samples of suspected food for analysis.

 

By Monday 23 January 1995, an analysis known as polymerase chain reaction (PCR) established the presence of the organism known as shiga-like toxin-producing E.Coli (SLTEC) in a sample of Garibaldi Garlic Mettwurst. It had already been established that a particular SLTEC, known as E.Coli 0111, was present in the faecal samples obtained from several of the patients.

That information, when combined with information obtained from the epidemiological investigation, and also aided by the identification of garlic mettwurst manufactured by Garibaldi Smallgoods Pty. Ltd. ("Garibaldi") as a common factor by two parents of sick children on Sunday 22 January 1995, was sufficient to prompt the Acting Minister of Health, Mr. Lucas, to make a public announcement at about 3.00p.m. on Monday 23 January 1995 which identified Garibaldi garlic mettwurst with a use-by date of 12 March 1995 as containing the toxin.

This announcement received wide publicity in the media, and was followed during the course of that week by several recall notices placed by Garibaldi, which initially recalled mettwurst with a wider range of use-by dates than that specified by the Minister, and which was later extended to all uncooked fermented products on 4 February 1995.

Subsequent detailed analysis has firmly established the link between uncooked fermented products manufactured by Garibaldi and the illness suffered by the people I have already referred to, and in particular the death of Nikki Robinson. The identification of the company's product, and its linkage with the death and severe illness of the children involved, had a catastrophic effect upon the company's business, such that it ceased operations on Monday 6 February 1995. This involved the downfall of one of the largest producers of smallgoods in South Australia, and the loss of more than 100 jobs, and has had a deleterious effect upon several other producers of smallgoods in this State.

Counsel assisting me during the inquest, Mr. M.I. Bell, outlined a list of issues during his opening address which he foreshadowed as being significant, and a number of other issues have arisen during the course of the proceedings. The inquest occupied a total of 60 days, and the evidence ran to 5788 pages. While I have not attempted to discuss every issue which has arisen, those issues which are relevant to my findings, and to any recommendations to be made pursuant to Section 25(2) of the Coroners Act, are discussed herein.

2. HAEMOLYTIC URAEMIC SYNDROME

(a) Explanation

Dr. Ken Jureidini, the Director of the Renal Unit at the WCH, described haemolytic uraemic syndrome as being a condition comprising a group of symptoms (hence a "syndrome" and not a "disease") which can present either in an epidemic form (as here), or in an endemic or sporadic context not having public health significance. It is not clear to me that the endemic or sporadic cases are necessarily different from the epidemic type in terms of their aetiology and it may be that with the availability of more sophisticated testing techniques developed during this epidemic, the distinction between the two types will become less distinct.

The process which takes place is that the victim eats or drinks a substance which is contaminated with E.Coli bacteria of a particular type which are capable of producing a toxin. These bacteria are commonly referred to as SLTEC (shiga-like toxin-producing E.Coli). These bacteria collect and colonise in the gut or lower intestine of the patient. During an incubation period of between one and fifteen days, although the patient may be slightly unwell, there are no particular symptoms. However, the patient then develops severe diarrhoea which often contains blood (haemorrhagic colitis) and which is often accompanied by severe abdominal pain. That condition lasts for about five days and may either resolve, or progress to haemolytic uraemic syndrome. It would appear that during this four to five day period, the SLTEC produces a toxin which then affects blood vessels in various parts of the patient's body, particularly, in children, the kidneys. This results in damage to the myriad blood vessels within the kidneys, and often results in the kidneys shutting down totally for several days. This damage also results in a condition known as haemolytic anaemia involving a profound breakdown of blood cells, and also results in a low platelet count (thrombocytopaenia) and elevated levels of urea (known as uraemia which is indicative of kidney failure), and also elevated levels of creatinine.

Although it is possible for adults to contract HUS, they more commonly contract a condition known as Thrombotic Thrombocytopaenic Purpura, which involves a similar process but often affects other organs including the pancreas and liver. For the purposes of this inquest, the medical evidence is that there is no relevant distinction between the two conditions.

If the condition is left untreated, a large percentage of patients will die from the effects of kidney failure (see the evidence of Dr. Jureidini at T.1251-1254). The response to the infection varies greatly from patient to patient, and probably depends upon the production of an antibody. I agree with the submission of Mr. Harris, counsel for WCH, when he said (at p.4-5 of his written submissions):-

"It is important to bear in mind that not every person who ingests material contaminated by SLTEC will become sick. Not every person who experiences abdominal pain and bloody diarrhoea will develop HUS. Not every person who develops HUS will require the same treatment. It is not possible to predict which of a given set of patients will suffer the most significant symptoms (Dr. Henning, p.1525).

Even if one did know which patients were at greater risk, as regards neurological dysfunction or cerebro vascular dysfunction, there are no specific prophylactic measures available to prevent the syndrome taking its course (Dr. Henning p.1527)".

 

Dr. James Paton, the molecular microbiologist who was chiefly involved in the PCR investigations, explained that the individual response of a patient may depend upon the individual's ability to produce antibodies, and may also be affected by such factors as the concentration of the organisms in the food being eaten, the distribution of those organisms in various parts of the food, and whether other food was eaten at the same time which may have some effect on the production of stomach acid, and the patient's general dietary habits. As Dr. Paton said:-

"The difficulty we have, nobody really understands the whole biology of this process and to a large extent we are guessing, but if, for example, we administer different doses of the same SLTEC producing E.Coli to experimental animals, if you administer the same dose and the animal was given the same diet, some may succumb, others won't".

(T.1607).

It may well be that this explains why some cases result in epidemics, while others are simply regarded as endemic or sporadic cases. As Dr. Paton explained, where, as here, it is likely that there were thousands of people exposed to the organism, only a certain proportion of the population either received enough of the organism, or had particular predisposing factors, to contract the illness. In another situation where there was a "spot contamination" at a butcher shop, for example, then the likelihood of an outbreak is very low and may only result in one case (see Dr. Paton's evidence at T.1748-1749).

What is particularly noteworthy about this organism is that, on Dr. Paton's evidence, it may be that a single bacterium is sufficient to cause an infection in an individual case. He pointed to studies carried out in America after a similar outbreak, involving hamburgers, took place two years ago. It was estimated that, before cooking, there were about 100 E.Coli bacteria in each hamburger patty. He explained:-

"One would assume that during the cooking process the majority of those would have been destroyed and, as a consequence of that, the attitude of the Americans has been that even one E.Coli.0157 is potentially an infective dose".

(T.1605).

(b) Treatment

Once HUS has been diagnosed, the only treatment available is prophylactic treatment to ameliorate the symptoms of the illness. Dr. Jureidini explained that attempts to fight the bacteria with antibiotics have been counter-productive, since the antibiotics cause an "explosive outflow of the toxins" (T.1413). As I have already said, the damage to blood vessels within the kidney may result in shutdown of kidney function, the treatment for which is haemodialysis. The syndrome may also affect blood supply to the bowel which may cause ischaemia (temporary interruption to the blood supply), or even, in some cases, an infarction (death of the tissue). As I will shortly outline, several of the children suffered this condition which necessitated abdominal surgery.

The blood vessels to the brain may also be affected, resulting in neurological symptoms experienced by many of the children. In the worst cases, this may result in infarction of tissues, commonly described as a stroke. As I will shortly describe, the most serious example of this was suffered by Nikki Robinson, and this resulted in her death.

These outcomes are entirely unpredictable. Even if the doctors knew that Nikki was in danger of having a stroke (which they could not), there was still nothing they could have done about it (T.1385).

The syndrome may also produce a variety of other symptoms, and I will describe these in more detail in due course.

3. THE DEATH OF NIKKI ROBINSON

(a) Background

Nikki Robinson was born on 14 November 1990. She lived with her twin sister Kelli-Ann, and her parents Judith and Andrew at Lewiston on the Adelaide Plains north of Adelaide. Two of Judith's children from a previous marriage also lived with them.

On 20 January 1995, Judith Robinson purchased a stick of mettwurst from the Foodland store on Old Port Wakefield Road at Virginia. At that time, she did not notice the brand, but remembered that it was about 18 inches long. She left the mettwurst in the refrigerator until Saturday 21 January 1995, when the family travelled to Morgan for the day to try out the new boat that Andrew had recently purchased. Mrs. Robinson prepared a picnic lunch of cold meat and salad, and she cut up most of the mettwurst into small pieces and included that with the meal. Everybody had some of the mettwurst for lunch that day, including Kelli-Ann.

Mrs. Robinson said that she had left about five inches of the stick in the refrigerator. On Monday 23 January 1995 she heard on the radio that Garibaldi garlic mettwurst was being recalled. She checked in the refrigerator to see if any of the mettwurst was left, but there was none. Since none of the family were ill at that stage, she did nothing more about it (T.48).

(b) First symptoms

Nikki's first symptoms appeared on Thursday 26 January 1995, when she complained of a sore tummy. She settled down that night, but the following morning, after eating breakfast, she began vomiting and complaining of stomach cramps and diarrhoea. Mrs. Robinson took Nikki to see Dr. Leow, whose surgery was in the same shopping centre as the Robinson's newsagency business. He diagnosed "a mild gastro" and wrote a prescription for Maxolon, and also suggested that Nikki take Panadol and Kao-magma (Exhibit C.31).

Dr. Leow found no other abnormality on examination, and so he did not order any blood or urine tests (T.657).

Mrs. Robinson said that Dr. Leow asked her if Nikki had eaten mettwurst and that she had said "yes", but was unable to remember the brand (T.49).

This seems somewhat at odds with the evidence of Dr. Leow, who said that although he knew that there was "some sort of outbreak of some form of gastro-enteritis", he was not aware of what might have been responsible for that spate of illnesses or that any product of any particular company had been recalled. He said that he was aware that it was due to "some sort of smallgoods" but he was not aware which company and which type of smallgoods was involved (T.655).

Further, Dr. Leow said that he was not aware that a diagnosis of HUS had been made in relation to this particular outbreak (T.656). In view of the amount of publicity which had been given to the Minister's announcement on 23 January, when combined with the publicity given to the recall notice published by Garibaldi on Thursday 26 January, and repeated on Friday 27 January (the day of Dr. Leow's consultation), I find this surprising. Dr. Leow explained:-

"Unfortunately with the hours I work, I tend not to watch TV or read very many newspapers, so what I hear tends to come from scraps of knowledge which I overhear on the radio or just may happen to read on any particular day". (T.655)

 

I am sure that there are many general practitioners in Dr. Leow's position. The fact that he was not aware of such an important public health issue, four days after such a prominent public announcement, is a matter for some concern.

A notice had been issued the previous week, on Thursday 18 January 1995, by the Health Commission giving notice that four cases of HUS had been reported and seeking information from general practitioners who may have seen such patients. The statement sought information concerning patients presenting with "haemorrhagic colitis, bloody diarrhoea lasting a few days, or thrombotic thrombocytopaenic purpura in the recent past" (Exhibit C.68a, SC2). Dr. Cameron, the head of the Communicable Diseases Control Unit at the SAHC, said that this notice had been distributed to doctors' surgeries on the Adelaide Plains via the IMVS specimen collection courier service, a system which they had found efficacious in the past. However, Dr. Leow denied receiving any notice of the outbreak (T660), and told me that he does not use the IMVS courier service.

The area of communication with general practitioners is one which could be the subject of useful study by SAHC. I appreciate that communicating with hundreds of doctors at once is a difficult task, but I am sure that, with modern communications, whether by facsimile machines, computer networks, or whatever, a scheme could be devised whereby such information could be disseminated to doctors on a more reliable basis. Indeed, I think that the issue is so important that a means of such communication (e.g. by subscription to an E-mail network) could be made a pre-condition to registration to practise medicine in South Australia. Other flow-on benefits from such a scheme (access to literature, etc.) would also be beneficial.

Dr. Leow said that had he been aware of the Minister's announcement on 23 January 1995, or had he been aware of an outbreak of haemolytic uraemic syndrome, he would have made enquiries about the consumption of mettwurst (T.663), and he would have referred Nikki to hospital for further investigation had it been confirmed to him that Garibaldi mettwurst had been consumed (T.664).

I am inclined to accept Dr. Leow's evidence that mettwurst was not discussed during that consultation on 27 January 1995. My assessment of Mrs. Robinson was that had Dr. Leow suggested any connection between Nikki's illness and the outbreak on the 27th, she would have gone straight to Virginia to investigate what type of mettwurst she had purchased the previous Saturday, rather than leaving it until after her visit to the Lyell McEwin Hospital the following day.

During the night of Friday 27 January 1995 and Saturday 28 January, Nikki continued vomiting and suffering from diarrhoea and abdominal pain.

(c) The Lyell McEwin Hospital

On the morning of Saturday 28 January 1995 Mrs. Robinson took Nikki to the Lyell McEwin Hospital, particularly because she was concerned that Nikki was becoming dehydrated (T.49). Nikki was seen at 7.20a.m. by a medical practitioner whose signature is indecipherable, and again at 8.15a.m. by the paediatric registrar, Dr. Saxon, whose notes indicate that there was a need to consider HUS "due to the epidemic associated with mettwurst" (see the notes, Exhibit C.34).

Although Dr. Saxon diagnosed mild dehydration, he also noted "mother keen on going home", and further noted "re-present if no improvement in 4-6 hours for IVT", obviously meaning that Nikki would receive treatment for dehydration had she not improved within that time. Mrs. Robinson confirmed that the decision as to whether Nikki should have been admitted or not at that time was left up to her (T.51), particularly in view of the fact that, as she said:-

"I am an enrolled nurse and thought I could take care of her."

(Exhibit C.4, p.2).

I therefore reject the implied criticism in Mr. Soulio's written submission, at p.6, as follows:-

"At 9.30a.m. Nikki Robinson was allowed to go home despite the noted Garibaldi mettwurst consumption".

 

In any event, I accept Dr. Jureidini's evidence that treatment given or not given at the Lyell McEwin Hospital had no effect on the outcome. He said:-

"Q. There was nothing, as I understand, that the Lyell McEwin people could or could not have done which would have affected whether Nikki was going to get HUS or not?

A. No, not in my opinion, no.

.....

Q. If she was going to get it she was going to get it, whether she was there or at the Children's?

A. Yes."

(T.1413).

(d) Connection with Garibaldi

Upon returning home, and no doubt as a result of her conversation with Dr. Saxon, Mrs. Robinson suggested that her husband attend at the Foodland supermarket at Virginia in order to ascertain the type of mettwurst she had purchased eight days earlier. He said that he attended at the supermarket and, after searching unsuccessfully, spoke to a shop assistant who, from Mr. Robinson's description, I conclude was the witness John Mead. Mr. Robinson said that there were only two brands of mettwurst on sale, small sticks which were made by Kalleske, and also larger sticks which were Garibaldi brand. Although he was not aware of the size of stick bought by his wife, when he returned home afterwards, she confirmed to him that she had bought the larger stick (T.97).

This evidence is directly contradicted by Mr. Mead, who said that he was shown a recall notice when he attended work on Friday 27 January 1995 and that Mr. Tassone, his co-manager, had already "actioned it" before he had arrived at work (T.1110). Mr. Tassone, on the other hand, gave evidence that the first notice he received was on 1 February 1995 (T.718), and that he believed everything came off display on either 1 or 2 February 1995, and that he was able to identify the day by virtue of the fact that he saw a newspaper article on 2 February 1995 about the death of Nikki Robinson (T.747). He said that nothing was done about withdrawing Garibaldi products from sale until after he heard about Nikki's death (T.747).

There is a considerable body of evidence, with which I will deal in due course, about the recall procedure which leads me to conclude that Mr. Tassone may be confused about the date on which mettwurst may have been removed from display in his store. It may be that some of the mettwurst was removed on the 26th or 27th, and that the balance was not removed until 1 or 2 February.

In any event, Mr. Mead is clearly wrong when he asserted that he remembered when a man came into the store (who could only have been Andrew Robinson), and the following conversation took place:-

"H.S.: I want to buy Garibaldi mettwurst".

"I.S.: We haven't had that for the last two weeks but we do have Tibaldi and Kalleske mettwurst".

"H.S.: No, I want a 250gm Garibaldi mettwurst because my little girl is sick and the doctor wants to figure out what she has eaten".

"I.S.: All we have is Tibaldi and Kalleske mettwurst".

(Exhibit C.57, p.1).

Mr. Mead was adamant that this conversation took place two weeks after the notice to remove Garibaldi from display was received, and was also adamant that it occurred after 2 February 1995 (T.1113). It is inconceivable that Andrew Robinson would have said "my little girl is sick" on an occasion two weeks after she had died.

In view of this apparent confusion on the part of Messrs. Mead and Tassone, I prefer the evidence of Mr. Robinson that when he attended the Foodland Store on 28 January 1995, he spoke to Mr. Mead and that Garibaldi mettwurst was on display. I also find that it was Garibaldi mettwurst which had been purchased by Mrs. Robinson the week before.

(e) Back to the Lyell McEwin Hospital

When her husband returned home and told her what he had ascertained at the supermarket, Mrs. Robinson returned to the Lyell McEwin Hospital with Nikki and was seen by Dr. Chan, the Paediatric Registrar, at 12.30p.m. (see casenotes, Exhibit C.34). At this time, it was noted that Nikki's bowel actions were bloody. An assessment of gastro-enteritis was made, mild dehydration was noted, and the casenotes were endorsed "watch for HUS".

Following Nikki's admission, she received intravenous hydration and repeated tests were performed in order to ascertain whether or not she was developing HUS. On admission, the only abnormal result was that Nikki had an elevated white cell count, but Dr. Jureidini gave evidence that this was not an indicator of HUS, rather it was merely an indicator of infection (T.1395). Further, on 29 January there was still no definite evidence of HUS (Jureidini, T.1411), and it was not until she was examined by Dr. Petek, a consultant paediatrician, on 30 January 1995 at 11.00a.m. that a diagnosis of emerging HUS was made.

Dr. Jureidini confirmed that the IMVS report dated 30 January 1995 considered by Dr. Petek, particularly the drop in haemoglobin count from 15.2 to 12.1, when combined with a very low platelet count of 41,000, the high white cell count of 33,000, the changes in the red blood cells together with the significant elevations in urea and creatinine, justified a diagnosis of emergent HUS by Dr. Petek at that time (see the evidence of Dr. Jureidini, p.1424-26).

In his submissions on behalf of the Robinson family, Mr. Soulio said:-

"Accordingly, while it may retrospectively be distressing to the family that Nikki Robinson was not admitted on first presentation to the Lyell McEwin Hospital, there appears to be nothing done or omitted which would have ultimately stopped her from developing HUS".

 

On the evidence I have just outlined, I find that submission difficult to understand. Nikki was not admitted on first presentation because her mother was confident that she could look after her, as an enrolled nurse. If, when the facts are viewed objectively, there was "nothing done or omitted which would have ultimately stopped her from developing HUS", I fail to understand why Nikki's non-admission on first presentation should be a ground for implied criticism.

There was a further criticism in Mr. Soulio's submission, at p.17-18, that there was a "delay" in the transfer of Nikki Robinson from Lyell McEwin Hospital to the Womens and Childrens Hospital on Sunday 30 January 1995. As I have said, the transfer was organised almost immediately after Dr. Petek had formed his diagnosis of emerging HUS. Dr. Jureidini confirmed that the diagnosis was appropriate, and that it could not have been made earlier on the medical evidence.

Dr. Jureidini confirmed that in those circumstances, there was no point in transferring Nikki to the WCH prior to that time.

In cross-examination of Dr. Jureidini, Mr. Soulio sought to establish that, in view of the fact that eight to ten patients had already been admitted to WCH at that stage with a diagnosis of HUS, many of whom were undergoing dialysis, and also taking into account Nikki's symptoms of bloody diarrhoea, low urine output and severe abdominal pain, she should have been transferred to WCH on 29 January. Dr. Jureidini specifically denied that, asserting that those symptoms were merely consistent with severe gastro-enteritis (T.1412), and that in those circumstances there was little to be gained by transfer, having regard to the stress and inconvenience that that would have caused, and having regard to the fact that the treatment on arrival at the WCH would have been the same, until a diagnosis of HUS was made (T.1412-13).

I therefore reject Mr. Soulio's submission that the fact that Nikki was not transferred to WCH earlier is indicative of "a lack of communication within the hospital system" (p.19). The doctors at the Lyell McEwin Hospital were aware from the earliest stage of the risk that Nikki would develop HUS and acted appropriately.

(f) The Womens and Childrens Hospital

The casenotes from the WCH (Exhibit C.61) demonstrate that Nikki was seen in the emergency department of the hospital at 1.28p.m. on Sunday 30 January 1995. The course of her treatment from there on is described by Dr. Jureidini in his evidence from page T.1299 onwards. He said that Nikki was seen initially by Dr. Bartell, the casualty registrar, and then by Dr. Roy, the resident, and then by him. He said that since Nikki still had some urine output at that stage, there was a possibility, albeit small, that she would not require dialysis (T.1301). However, her abdominal pain was in the more severe category.

Nikki was observed for the balance of 30 January, and on the morning of Monday 31 January 1995 a catheter was inserted in the femoral artery under general anaesthetic. Having regard to the level of urea, which had slightly more than doubled in the previous twelve hours, the decision was taken that Nikki would require dialysis, and that commenced at about 4.00p.m. that afternoon. Although there was some difficulty concerning the flow through the machine, Dr. Jureidini regarded the initial dialysis session as adequate (T.1305).

At about 7.15 or 7.20p.m. it was noted that Nikki's pupils were unequal in size, the right eye being a little more dilated than the left. Dr. Jureidini was in the intensive care unit, where Nikki was situated, at the time. A CT scan was performed almost immediately. That disclosed that at least two large cerebral infarctions (death of brain tissue due to interruption to blood supply) had taken place, and associated swelling of the brain tissue had also occurred (T.1322).

Having regard to the swelling, a "Richmond screw" was inserted in order to monitor intracranial pressure, and dialysis was continued throughout that night.

However, Nikki's condition continued to deteriorate, and she died at 8.10a.m. on Tuesday 1 February 1995.

(g) Cause of Death

A post mortem examination of Nikki's body was conducted by Dr. Roger Byard, the consultant histopathologist at the WCH on 2 February 1995. In his report (Exhibit C.3a), Dr. Byard summarised his main findings at autopsy as follows:-

1. Haemorrhagic infarcts of L. parietal and R. frontal lobes of brain with diffuse hypoxic ischaemic encephalopathy.

2. Disseminated sepsis and widespread putrefactive change with:

(a) Gas production within abdominal cavity, subcutaneous tissues and organ parenchyma.

(b) Gram-positive rods demonstrated in brain, liver, spleen, pancreas, kidney.

(c) Post-mortem cultures of Staphylococcus aureus and Clostridium septicum.

3. Acute inflammation with transmural necrosis/ischaemic damage to colon.

4. Richmond screw insertion.

5. Ascites, pleural effusions and tissue oedema.

6. Pulmonary congestion and oedema.

7. Thymus : atrophy.

8. Chronic interstitial inflammation of submandibular gland.

Dr. Byard stated the cause of death as:-

1. Haemorrhagic infarction of brain with diffuse hypoxic ischaemic encephalopathy.

2. Bacterial septicaemia.

 

He added a further comment:-

"Given the presence of advanced putrefactive changes it is not possible based solely on the autopsy findings to be certain of the underlying aetiology of the haemorrhagic infarcts/hypoxic ischaemic encephalopathy and disseminated sepsis, although these would be quite compatible with sequelae to the clinical diagnosis of haemolytic uraemic syndrome. Death was due to a combination of factors involving shock from disseminated bacterial sepsis, most likely secondary to ischaemic damage to the colon, and haemorrhagic infarcts of the brain".

 

In his submissions, Mr. Soulio suggested that at T.1354, Dr. Jureidini disagreed with the post mortem cause of death.

I think it is more accurate to say that Dr. Jureidini disagreed with the comment made by Dr. Byard, as outlined above. At T.1354, Dr. Jureidini said:-

"I believe from the clinical state of the situation that the primary event was brain death",

 

adding that if there was any ischaemia, or even infarction of the bowel, this was secondary to the cerebral episode (T.1357).

In reality, there is no real dispute between Dr. Jureidini and Dr. Byard. Dr. Byard conceded that the brain haemorrhage and infarct occurred first, as a result of which death occurred (T.2708). He said that Nikki's already compromised bowel then created disseminated sepsis, and by the time Dr. Byard saw her more than 24 hours later, it was no longer possible to determine precisely what had occurred.

Accordingly, I consider it appropriate that the cause of death should be recorded simply as

"haemorrhagic infarction of the brain with diffuse hypoxic ischaemic encephalopathy consequent upon Haemolytic Uraemic Syndrome".

 

In view of the evidence, and having regard to the submissions of Mr. Bell, as well as those of Mr. Harris on behalf of the WCH, and the fact that none of those submissions were opposed by other counsel, particularly by Mr. Soulio, of counsel for the family, I can see no ground for criticism of the treatment administered to Nikki Robinson at the Womens and Childrens Hospital. On the contrary, it seems to me that the treatment administered was exemplary, consistent with modern practices in the field, and, particularly in view of the heavy demand being placed upon resources in the midst of such a serious epidemic, to be applauded.

4. OTHER CHILDREN DIAGNOSED WITH HUS

As I have already mentioned, Nikki Robinson was the fourteenth of 23 children admitted to the Womens and Childrens Hospital with a diagnosis of HUS. Although this inquiry has not been specifically concerned with each of those other cases, since to do so would have been beyond my jurisdiction, the chronology of each of those cases is important to illustrate the context in which Nikki Robinson's illness occurred and was treated, and the context in which the public health investigation, the recall procedure and other aspects of the matter took place. Accordingly, I will briefly outline the circumstances of each case.

Michelle Vanderkop, aged five months, was with her mother when they visited the Woolworths Supermarket at North Park, Enfield. Ms. Vanderkop described how she tasted some samples of mettwurst which were being offered on a tray. Although she cannot be precise about the date, she thought that the event took place between 19 and 23 December 1994 (T.511). Ms. Vanderkop returned at a later time and spoke to Mr. Rowell, an employee of Woolworths, who told her that the mettwurst was Garibaldi brand. Although Michelle did not eat mettwurst, it is a matter of conjecture whether she may have become infected with HUS via her mother's hands.

After taking her to a general practitioner who diagnosed a gastro-intestinal infection, Ms. Vanderkop took Michelle to the WCH on 25 December 1994, when she was also told it was "gastro", and that she should take the baby home and keep her fluid intake up (T.514). She returned to the WCH on the same day when the baby began coughing blood, and Michelle was admitted. Michelle received dialysis for a total of eleven days from there on after a diagnosis of HUS was made.

Michelle appears to have made a good recovery from her illness, although her mother reports that she still has difficulty sleeping. Her mother told me that she won't know if Michelle has suffered permanent kidney damage until she turns two (T.522).

Joshua Sadler, aged two years, ate mettwurst three or four days prior to having a convulsion on 2 January 1995. His mother's evidence was that she had purchased the mettwurst at Hallett Cove Foodland Supermarket, that she thought it was Garibaldi brand, but she was unable to recall if it was garlic or plain. She described it as a stick about 18 inches long, and although she was not sure, she thought the use-by date was March 1995 (T.177). Although someone from the Health Commission attended at her house to collect any samples, there was none of the mettwurst left (T.173).

On 2 January 1995 Joshua developed a fever and had a convulsion that night. He was admitted to Flinders Medical Centre but discharged the following day. His health improved for a couple of days until Thursday 5 January 1995, when he developed diarrhoea and vomiting. Mrs. Sadler returned to Flinders Medical Centre where he was admitted (T.170). He was diagnosed as having HUS on Monday 9 January 1995. He was transferred to the WCH on Tuesday 10 January, and underwent dialysis for a total of nine days. He was discharged from hospital on 1 February 1995.

Although Joshua has also made a promising recovery, he continues to suffer from hypertension for which he is on medication, and his mother reports that his behaviour has become more demanding following his illness.

Timothy, aged two years, ate mettwurst purchased by his mother at the Foodland Supermarket in Jacob Street, Gawler a couple of days before Christmas 1994 (T.125). Mrs. Faulkner said that she always bought Garibaldi mettwurst. On about 18 January 1995 officers of SAHC attended at the home and collected the remaining mettwurst which still bore the Garibaldi label, and it was established that it was Garibaldi garlic mettwurst, 575gm, with a use-by date of 12 March 1995.

Timothy developed diarrhoea on about 6 January 1995 and his mother noticed that it contained blood and had a particularly offensive smell (T.126). He was lethargic, weak and puffy in the face and seemed "out of it". He was taken to the Hutchinson Hospital at Gawler on Wednesday 11 January 1995 and admitted, and on 12 January 1995 he was transferred to the Lyell McEwin Hospital. By 14 January 1995, HUS had been diagnosed, and he was transferred to the WCH where he received dialysis for a total period of seventeen days until he was discharged on 28 January 1995.

Timothy appears to have made a good recovery although his mother reports that he has had hallucinations at night. He was required to attend outpatients at WCH for ongoing monitoring of his condition for some time after his discharge.

Nicholas, aged three years, ate mettwurst at his grandmother's house on several occasions between Christmas and 11 January 1995. His grandmother, Mrs. Grungo, said that although she was unable to specifically recall the brand of mettwurst she purchased, she usually bought Garibaldi garlic mettwurst, either from the Woolworths Supermarket at Findon or the Bi-Lo Supermarket at Greenacres (T.162). None of the mettwurst remained for sampling after Nicholas became ill (T.163).

On Wednesday 11 January 1995 Nicholas first developed symptoms of frequent diarrhoea, and this continued until Saturday 14 January. He had developed abdominal pain and it was noticed that his bowel movements had become bloody (T.163). That evening, Nicholas was examined by a family friend who is a doctor, and he suggested that Nicholas be taken to either the WCH or Lyell McEwin Hospital if he had not improved. On Sunday 15 January 1995 he was taken to the Lyell McEwin Hospital, and admitted and was placed on a drip, and the following day he was transferred to the WCH where a diagnosis of HUS was made.

Nicholas remained in hospital for 26 days, and received dialysis on a total of fourteen days. He was discharged on 10 February 1995 (T.142). He continued to require check-ups following his discharge, and medication for hypertension. He has a restricted diet. His mother has also noted that his behaviour has become more demanding and highly-strung since his illness, and that he continues to have hallucinations or "night terrors" while sleeping (T.143).

James, aged 12 years, had a mettwurst sandwich for lunch with his father and brother Steven on Sunday 8 January 1995. His father said that the sandwich contained five or six pieces of mettwurst, which he identified as Garibaldi garlic mettwurst, and which he had purchased from Con's Fine Foods in the Central Market, the previous day, Saturday 7 January (T.192). Mr. Branson did not look at, and was not aware of any use-by date. He said that the remaining portion of mettwurst was handed to an officer of the SAHC, Colin Clark, on 21 January 1995. Although it was confirmed as Garibaldi mettwurst, no use-by date was visible.

James first developed diarrhoea on Thursday 12 January 1995, although his father had noticed that he was lethargic the day before (T.190). By Saturday 14 January his diarrhoea had become worse, and by Sunday he was passing blood. On Sunday 15 January James was taken to Flinders Medical Centre, where he was admitted, as the doctors were concerned that he was becoming dehydrated. In hospital he became progressively more agitated and "jumpy", and it was noticed that his speech had quickened (T.190-191).

On Wednesday 18 January the blood tests indicated that James was losing his kidney function and that dialysis would be required, so he was transferred to WCH where he was admitted and underwent dialysis on a total of 18 days until his discharge on 3 February 1995. Following discharge, James continued to attend regular clinics at the hospital, and although he has made a good recovery, his parents report that he continues to be lethargic and withdrawn following his illness.

Cohen White, aged two years, ate mettwurst over the Christmas/New Year period, although it is not possible for his mother to precisely identify the date (T.215). She purchased the mettwurst, which she identified as Garibaldi garlic mettwurst, from the Bi-Lo Supermarket at Mount Barker at some time during that period, although she is unable to be more precise (T.214). She was unaware of the use-by date. Her husband brought the remaining piece of mettwurst to the WCH for testing on Saturday 21 or Sunday 22 January 1995 (T.224).

Cohen first became ill on Tuesday 10 January 1995 with diarrhoea and vomiting throughout the night. This persisted for two days or so until he began to experience abdominal pain, described as "stomach cramps" (T.216). Mrs. White took both Cohen and his sister Nikki to the WCH on Monday 16 January, at about 7.00p.m., when they were examined but not admitted. The casualty staff asked Mrs. White to return with a faecal specimen for testing. On Wednesday 18 January Mrs. White took Cohen to their general practitioner, who recommended that she return to the hospital, where he was admitted and blood tests disclosed that he had HUS.

Although Cohen did not require dialysis, he received two blood transfusions until his discharge on 24 January 1995.

He has made a good recovery, although he needed to return to the HUS clinic for checking.

Nikki, aged five years, ate Garibaldi garlic mettwurst in the same circumstances as her brother Cohen between the Christmas and New Year period. She first developed symptoms two days later than her brother, on Thursday 12 January, in the form of diarrhoea, stomach cramps and vomiting (T.217). She was eventually admitted to the WCH on 18 January 1995, where she remained until 24 January 1995. Nikki was also fortunate enough to avoid dialysis, although she underwent one blood transfusion and dialysis remained a possibility throughout her stay in hospital.

She, too, appears to have made a full recovery (T.222).

David, aged one year, did not, so far as his mother is aware, eat mettwurst at all. She purchased a portion of mettwurst, two to three inches long, from the Woolworths Supermarket at the Marion Shopping Centre, in the delicatessen section, on 29 or 30 December 1994 (T.930). She was unable to recall whether it was salami or mettwurst, whether it was garlic or plain, nor did she know what brand it was (T.931). No sample was available for testing after David became ill.

David first displayed symptoms on Friday 6 January 1995 in the form of diarrhoea and began vomiting on the evening of Saturday 7 January (T.933). By the following Wednesday 11 January, his condition worsened and he was admitted to Warrnambool Base Hospital in the course of his parents' holiday journey back to Sydney. He was discharged from hospital on Friday 13 January, by which time his condition had improved somewhat and they continued their journey. By Sunday 15 January David's condition worsened again and his parents noted blood in his diarrhoea and he was admitted to the Woden Valley Hospital in Canberra (T.935), from where he was transferred by air ambulance to the Prince of Wales Hospital in Sydney on 18 January 1995 (T.927). David received dialysis for a total period of 23 days, during which time he had a number of seizures and suffered left-sided paralysis, various other neurological symptoms, anaemia, temporary diabetes, and bleeding behind the eyes.

David was eventually discharged on 17 February 1995, but he was still suffering nightmares, problems with his eyes, some residual left-sided weakness, his speech has been affected to some extent, and it would appear that he has lost 70% of his kidney function. His parents have been told that he will require a kidney transplant (T.940). He must maintain a special diet, his blood pressure is erratic and he still has problems sleeping (T.938-40).

Emma, aged eight years, consumed mettwurst some time after it was purchased by her mother on 31 December 1994, when she bought the first stick, or 9 January 1995 when she bought the second stick. Mrs. St.Clair confirmed that on both occasions the product was Garibaldi garlic mettwurst (T.233), although she was unable to recall the use-by dates. No sample remained after Emma became ill, so no analysis was done on the mettwurst.

On Sunday 15 January Emma developed symptoms of diarrhoea and was feeling generally unwell, but her condition improved somewhat until Tuesday evening on 17 January, when Emma developed a stomach ache which, by Wednesday 18 January, had become more severe. She had also developed a fever and was vomiting. Her mother took Emma to the local general practitioner, who diagnosed "gastro". On Thursday 19 January she developed blood in the diarrhoea. She was taken to the local doctor again, and then to the Noarlunga Hospital, and the staff there had arranged for an analysis of a faecal sample which was taken at the same time.

By 21 January 1995 her doctor was in contact with the WCH, who suggested that she be brought in and this occurred and she was admitted that day. She underwent dialysis on a total of 17 days from that time until her eventual discharge on 7 February 1995. Although Emma has made a good recovery, she continued to require medication for hypertension, and her mother reports that she has also suffered nightmares, lethargy and headaches.

Bryn, aged four years, consumed mettwurst on Saturday 14, Sunday 15 and Monday 16 January 1995 after his mother purchased it from the Bi-Lo Supermarket at Murray Bridge on Friday 13 January. She identified it as Garibaldi plain mettwurst (T.280), although she was unable to identify a use-by date. There was some mettwurst remaining on 24 January 1995 when Mrs. Fromm took it to the WCH for testing.

Bryn first developed symptoms on Saturday 14 January when he developed a temperature. This is unusual in the sense that this symptom developed on the same day as the initial consumption. On Tuesday 17 January Bryn's mother and father had also developed some symptoms of stomach pains and nausea, which remained for several days but which eventually eased (T.285). By Thursday 19 January Bryn had developed blood in his diarrhoea and on Friday 20 January his mother took him to Dr. Crompton at Mannum. He diagnosed "gastro", but since Bryn's symptoms persisted throughout that night, his mother returned Bryn to the Mannum Hospital the following day, Saturday 21 January, where he was admitted, apparently with the intention that he remain overnight. However, later that day he was transferred by ambulance to the WCH, as the nurses at Mannum had confirmed the presence of blood in the faeces (T.288).

Bryn remained at the WCH until Monday 23 January when he was discharged, but on Tuesday 24 January Dr. Roberton telephoned Mrs. Fromm and advised her that the tests on Bryn's faecal specimens had proved positive and that the diagnosis was that he had HUS. Accordingly, he was re-admitted that afternoon but only remained until Friday 27 January. While he was in hospital, Bryn's blood was tested frequently but he was able to avoid both dialysis and blood transfusion. He remained very pale and listless for a long time after his discharge (T.290). Apart from that, Bryn has made a full recovery.

Dana, aged eleven years, consumed salami in company with her mother and brother on Thursday 19 January and again on Sunday 22 January 1995. Mrs. Hutchinson had purchased the salami on 19 January from the Woolworths Supermarket at Aberfoyle Park, known as "The Hub", in the delicatessen section. She said that it was sliced and had been stored in refrigerated meat trays (T.319).

Mrs. Hutchinson said that she telephoned the supermarket on Monday 30 January when an employee told her that the sliced salami had been made by Garibaldi (T.328). No use-by date is known, and no sample remained for testing after Dana became ill.

Dana first displayed symptoms on Tuesday 24 January 1995 in the form of stomach cramps, vomiting and diarrhoea. The following day she was taken to Dr. Hanson, a general practitioner. On Thursday 26 January in the early morning, blood in Dana's faeces was noted and she was taken to the Flinders Medical Centre where her mother was informed that HUS was suspected (T.321). By Saturday 28 January Dana's kidneys were showing signs of failing, so she was transferred to the Womens and Childrens Hospital where the diagnosis was confirmed.

On 29 January 1995, dialysis commenced and continued on a further 21 days until her discharge on 22 February 1995. While in hospital, Dana suffered a stroke while undergoing dialysis, as a result of which she was admitted to intensive care on two occasions. She suffered a left-sided haemiparesis (paralysis on one side), but has made a remarkably good recovery from such a dangerous complication. She has continued to require medication for hypertension and may have impaired liver function. However, her only noticeable disability is double vision on looking upwards (T.325-6).

Kelly, aged seven years, consumed Garibaldi garlic mettwurst at a party at the house of friends of her parents on Saturday 21 January 1995. The mettwurst had been purchased from the Foodland Supermarket at Surrey Downs. The person who purchased the mettwurst, Kerry Hudson, confirmed that the mettwurst came from a 750gm stick of Garibaldi garlic mettwurst, although she was unable to recall the use-by date, and no sample remained for testing after Kelly became ill.

Kelly first developed symptoms on Tuesday 24 January 1995 in the form of "bubbly tummy", but on 25 January she had developed vomiting and diarrhoea, and by 26 January blood was noted both in the vomit and in faeces (T.394).

In the morning of Thursday 26 January 1995 Kelly was taken to see Dr. Skeklios at Wynn Vale, and they returned later that afternoon, and again on 27 January. On 28 January they consulted Dr. Ketteridge, who did not advise hospitalisation (T.397).

Later that evening, Kelly started to hallucinate and the following morning they returned to Dr. Ketteridge, who then accompanied them in the car to Modbury Hospital. Later that day Kelly was transferred to the Womens and Childrens Hospital by ambulance (T.399). Kelly underwent seventeen days of dialysis while in hospital, and also displayed marked neurological symptoms, including verbally aggressive behaviour, which was most uncharacteristic. She developed a high temperature and hypertension and diabetes.

On 3 February 1995 Kelly suffered a stroke, and later in February it was discovered that she required abdominal surgery (T.404). About a week after surgery, Kelly suffered another stroke which was fortunately only temporary in nature, the resulting blindness disappearing after a week. Kelly also required numerous blood transfusions while in hospital and was eventually discharged on 14 March 1995.

At the time Mrs. Owen gave evidence, Kelly required a further blood transfusion. She required continued periodic visits to hospital, her kidney functions were improving, she continued to require anti-convulsant medication, as well as medication for her low haemoglobin. She continued to display behavioural changes, and remained weak and nauseous and lethargic (T.414). It is not known whether Kelly will suffer permanent loss of kidney function, and if so to what extent.

Jack, aged five years, ate Garibaldi garlic mettwurst on Friday 20 January 1995, the same day his mother had purchased a 750gm stick of it from the Cash and Carry store at Kent Town. His sister Hannah consumed a similar amount. According to his mother, Jack also consumed mettwurst the following day in sandwiches (T.897). About two inches of the stick remained after Jack became ill and was delivered to the Childrens Hospital on 2 February 1995 for testing.

Both Jack and his sister first developed symptoms on Monday 23 January 1995 in the form of diarrhoea. His symptoms gradually developed until Wednesday 25 January when his mother noticed blood in his faeces and that he appeared pale (T.898). Later that evening Mrs. Culshaw took her children to the WCH where both urine and faeces were tested. She was told that Hannah was clear, but Jack was admitted that evening to Susanne Ward (T.900). His neurological symptoms became worse and he began to hallucinate. A catheter was inserted on 30 January and dialysis then commenced and continued on a further 47 days.

Jack's stomach pains began to worsen during mid-February, to the extent that he required abdominal surgery on two occasions during his hospitalisation. This was dangerous because Jack's renal function was low, and his ability to combat infection compromised. However, the surgery had to be performed when it became unavoidable. This must have caused his parents great distress. The dialysis continued until 17 March 1995 and Jack was not discharged until 29 March 1995.

Jack has continued to suffer significant after-effects of his illness. He will require further abdominal surgery, and the return of his kidney function will remain problematic. He has been emotionally affected by his illness and continues to require medication for his ongoing hypertension and other symptoms.

I have already outlined in detail the circumstances of Nikki's ingestion of mettwurst, the onset of her illness and its tragic consequences.

Travis, aged three years, ate Garibaldi salami in a roll on Friday 13 January 1995. The rest of his family had a similar meal on that day. Mrs. Posthuma had purchased the salami from Woolworths Supermarket at The Hub, Aberfoyle Park, on Thursday 12 January. The salami was already sliced by the supermarket. Evidence from the service deli manager, Ms. Tracy King, indicates that only Garibaldi brand salami was displayed in sliced form by the supermarket at that time (T.959). No sample was available for testing after Travis became ill.

Travis first displayed symptoms on Thursday 26 January 1995, when he complained of a sore stomach and diarrhoea. By the following day his faeces contained blood and there was no improvement over the next three days, notwithstanding that she had consulted Dr. Pike at the Aberfoyle Park Medical Centre on 27 January and he had prescribed Bactrim. By 30 January Travis was no better, so Mrs. Posthuma took him to Dr. Jacobsen, a general practitioner on Marion Road. He also recommended conservative treatment. However, later that day Mrs. Posthuma telephoned Dr. Jacobsen, told him that Travis was unable to keep anything down and the doctor referred her directly to Flinders Medical Centre. They attended at Flinders Medical Centre but Travis was transferred almost immediately to the WCH at about 10.30p.m. that evening (T.266). Dialysis was commenced within three hours as Travis' kidneys had shut down completely \by the time he arrived at the WCH (T.268). He also received blood transfusions and dialysis on a total of twelve days until his discharge on 15 February 1995.

Travis has made a good recovery from his illness, although his mother remarked that he tires quickly.

Lauren, aged five years, consumed Garibaldi garlic mettwurst on Sunday 22 January 1995 when it was served up on a platter of cold meats by her mother. Mrs. Adamcewicz said that the mettwurst had been purchased from the Bi-Lo Supermarket at Morphett Vale on either Tuesday 17 or Thursday 19 January 1995. She identified it later as Garibaldi garlic mettwurst with a use-by date of 5 April 1995 (T.301-2). Mrs. Adamcewicz was able to remember these details because she heard the announcement on 23 January that the recalled mettwurst had a use-by date of 12 March, and so she went home and checked the mettwurst which was remaining in her refrigerator, and ensured that it did not fit that description (T.302). A portion of the mettwurst was still available after Lauren became ill, and it was taken to Flinders Medical Centre on 29 January 1995 (T.305).

Lauren's first symptoms appeared on Friday 27 January 1995, in the form of diarrhoea and stomach pains. Mrs. Adamcewicz took Lauren to Dr. O'Connor at Morphett Vale that day, who questioned her about consumption of mettwurst but diagnosed a gastric illness and recommended keeping fluids up. Dr. O'Connor took a faecal specimen at that stage.

Later that day Lauren began passing mucous and blood in her faeces, and her mother consulted the after-hours locum service, who advised that she attend Flinders Medical Centre immediately. Mrs. Adamcewicz complied and Lauren was admitted to Flinders Medical Centre that evening (T.304). By 31 January 1995, Lauren was showing signs of renal failure so she was transferred to the WCH and a catheter was inserted and she commenced dialysis that day. Lauren underwent dialysis on twelve days thereafter until her discharge on Thursday 16 February 1995.

Lauren appears to have made a good recovery from her illness and apart from what her mother describes as "a few night terrors" and an increased susceptibility to colds (T.309), she does not appear to have suffered serious disability.

Aaron, aged six years, ate mettwurst at the house of his next-door neighbours, Mr. and Mrs. Leske, on Saturday 28 January 1995. Mrs. Leske had purchased Garibaldi plain mettwurst at the Foodland Supermarket at Mount Barker Road, Stirling on Friday 27 January 1995 (T.459). Mrs. Leske said that she checked the use-by date on mettwurst at the time and was satisfied that it did not come within the batch mentioned in the recall notice, namely 12 March. The other distinction was that the recalled mettwurst was Garibaldi garlic mettwurst whereas this was plain mettwurst.

After Aaron became ill, a sample of the mettwurst, together with the wrapper which Mrs. Leske had retrieved from the rubbish bin, was handed to Mrs. Ross, who handed it to Dr. Goldwater at the WCH when Aaron was admitted on 31 January 1995.

Aaron first became ill on Sunday 29 January 1995, while he was still staying with the Leske's. He became extremely thirsty and complained of stomach pains (T.461). Mrs. Ross took Aaron to her local doctor, and took with her a sample of Aaron's faeces. However, at that stage she was unaware that Aaron had eaten mettwurst (T.446). On the afternoon of 30 January 1995 Mrs. Ross spoke to Mrs. Leske, who then recalled that Aaron had eaten Garibaldi mettwurst two days earlier. By that stage Aaron's faeces were bloody.

Mrs. Ross rang WCH during the afternoon and was advised to see her local doctor if his condition had not improved. The following morning Mrs. Ross consulted Dr. Moss, who advised her to take Aaron to the WCH immediately. She did so and he was admitted that day and HUS was diagnosed. A catheter was inserted on 1 February and dialysis commenced soon afterwards, and occurred on a total of twelve days while Aaron was in hospital until he was discharged on Thursday 16 February 1995.

Aaron appears to have made a good recovery from his illness, and although there were restrictions on his diet soon after discharge, he now appears to be living a normal life.

Michael, aged eleven years, ate Garibaldi garlic mettwurst during a picnic-style lunch with his family on Sunday 22 January 1995 (T.374). His mother had purchased the mettwurst from the Bi-Lo Supermarket at The Hub, Aberfoyle Park, the previous day. She identified it as Garibaldi garlic mettwurst (T.373). She identified it as a "bonus size", although she was unable to specify a use-by date. No sample was available for testing after Michael became ill.

Michael's symptoms first appeared on Saturday 28 January in the form of vomiting, diarrhoea and stomach cramps. On Sunday 29 January his breathing had become laboured and he was taken to a general practitioner, Dr. Measday, who diagnosed either "gastro" or appendicitis. On Dr. Measday's advice, Mrs. Bailey took Michael to Flinders Medical Centre for a blood test. At Flinders Medical Centre a blood test and X-rays were taken, and Michael was admitted to the hospital that day with a diagnosis of appendicitis. On 30 January 1995 he underwent surgical removal of his appendix, which was found to be "slightly inflamed" (T.378). However, notwithstanding the removal of his appendix, Michael continued to suffer vomiting and diarrhoea and blood was noticed in his faeces (T.379).

By 2 February 1995 Michael's symptoms were such that HUS was suspected, and he was transferred to WCH that day. Michael remained at the WCH until 11 February 1995 and underwent dialysis on six days during his stay in hospital.

Michael appears to have made a good recovery from his illness, apart from what his mother thought was an increased incidence of throat and ear infections (T.382). It would appear that the loss of his appendix will not constitute an ongoing problem for him.

Scott, aged five years, ate Garibaldi garlic mettwurst on 24 January 1995, his mother having purchased it from the Welland Continental Deli on Saturday 21 January (T.344). She said that she heard the Minister's announcement on Monday the 23rd, but checked the use-by date and noticed that it was 5 April 1995 and concluded that it was outside the period specified in the notice. Accordingly, the following day her husband allowed Scott to eat the mettwurst.

Scott's symptoms first appeared on Wednesday 1 February in the form of bloody diarrhoea. On that day Mrs. Granton consulted Dr. Fitzgerald, who thought that it was only a viral infection (T.347). Later that day she rang her family general practitioner, Dr. Kummeron, who advised her to take her son to the WCH if she was unhappy with Dr. Fitzgerald's advice. She complied with that suggestion and Scott was admitted that same day and a diagnosis of HUS was made several days later. He commenced dialysis on 4 February 1995 and underwent dialysis on eighteen days after that. During his stay in hospital, Scott suffered complications in the form of diabetes and a secondary blood infection, and also suffered hallucinations.

He was discharged on 14 March 1995, and although he has significantly recovered, he still attends the HUS clinic on a regular basis, has medication for hypertension and is on a restricted diet. Scott is also showing signs of permanent kidney damage and there is a concern that one of his kidneys is shrinking and the prognosis is uncertain. The damage to his pancreas may also cause problems with diabetes in the future. Mrs. Granton also noticed that Scott is very emotional and is easily upset (T.362).

Samuel, aged nine years, consumed mettwurst on 24 January 1995. Samuel was at that time in the care of his elder sister, Carolina, while their parents were overseas in Chile visiting relatives. The mettwurst had been purchased from Woolworths at Parabanks, Salisbury, on 23 January 1995 in the form of "shaved mettwurst" from the "deli section" of the supermarket (T.424). No sample was available for testing after Samuel became ill. Evidence was taken from Mr. Weckert, the manager of the service deli department of the supermarket, who confirmed that the shaved mettwurst would have been Garibaldi's product (T.1135).

Samuel's first symptoms appeared one day after consumption, when he suffered nausea, vomiting, diarrhoea, and stomach cramps (T.426). His symptoms persisted for the balance of that week and on Monday 30 January his sister sent him for the first day at school. He had pain during the day and felt drowsy. When Carolina collected him from the railway station after school, he was hunched over with pain and so she took him to the Europa Clinic at Salisbury (T.429). The doctor suggested that she give Samuel weak cordial and Panadol for his condition, but he continued with vomiting and diarrhoea. On the following day, Tuesday 31 January, Carolina called the locum service, and the locum confirmed that he thought that Samuel would be well enough to go to school the following day (T.431).

On 1 February 1995 Samuel developed diarrhoea and remained at home for the balance of that week until Friday 3 February when his sister took him to the WCH on the suggestion of her grandmother.

After his admission, Samuel was catheterised on Saturday 4 February, and commenced dialysis on 5 February. He was dialysed on a further fifteen days until his discharge on 22 February 1995. He also required a total of five blood transfusions during his stay and displayed considerable neurological symptoms, particularly hallucinations and aggressive behaviour. He has been taken back to the hospital on two occasions since his discharge with symptoms of severe headaches and vomiting. His headaches have eased somewhat since his discharge and he has continued to display uncharacteristic behaviour, moodiness and aggressiveness. He also requires medication for hypertension on an ongoing basis.

There is no evidence that Dylan, aged six months, consumed Garibaldi mettwurst or salami at all. His mother said that she purchased sliced garlic mettwurst in a vacuum pack from the Blackwood Foodland Supermarket in early December 1994 (T.549). However, this evidence is denied by the Foodland employee, Helen Thede, who said that pre-sliced mettwurst was never sold in that section at the relevant time (T.1070), although she did concede that it may have been sliced if a particular customer requested it (T.1079).

In any event, Mrs. Paterson said she used the mettwurst as pizza topping on about 14 December 1994 (T.550), and although she left some in the fridge which was later eaten, she is unable to recall who ate it. It is highly unlikely that Dylan consumed any.

In February 1995 Dylan began showing signs of illness, including rashes and low blood/platelet levels which she thought may have been connected with steroid medication he was then taking, but it was not until Thursday 9 February 1995 that he developed diarrhoea which was bloody (T.558). Mrs. Paterson took Dylan back to Flinders Medical Centre on Friday 10 February, but he was not admitted as the doctors suggested that the blood may have been due to the steroids (T.558). However, his condition continued to deteriorate and she returned to Flinders Medical Centre on 11 February and again on 13 February, when Dylan was admitted and transferred to the WCH that day (T.559). That same day he underwent a blood platelet transfusion, and he then commenced dialysis, which continued on a further fourteen days until his discharge on 6 March 1995.

Following his discharge, he returned to the HUS clinic on a weekly basis. He still requires medication for hypertension.

Dr. Jureidini said that Dylan is still being carefully monitored, as he has less than 30% of his kidney function at present, and the fact that he was so young when he contracted the illness leads to a poor prognosis (T.1473).

There is no evidence that Abbey Hamblyn, aged three years, ate Garibaldi mettwurst or salami at any stage, nor is there evidence as to how she may have had "secondary contact" with Garibaldi products. Her first symptoms appeared on 7 February 1995 when her mother noticed that she was tired and pale (T.535), and by Thursday 9 February she had begun vomiting. Mrs. Hamblyn consulted her local general practitioner, who requested provision of a faecal sample (T.537). That night, Mrs. Hamblyn noticed that Abbey had begun having nightmares. By Saturday 11 February 1995 she consulted Dr. Hocking, who arranged for a urine sample to be submitted. On Monday 13 February Dr. Hocking contacted Mrs. Hamblyn, advising that the original contained traces of blood and protein. As a result of these developments, Mrs. Hamblyn took Abbey to Flinders Medical Centre at about 2.00p.m., when she was admitted and blood tests were taken. HUS was diagnosed and Abbey was transferred to WCH and the diagnosis was confirmed. She was catheterised at about midnight that night and dialysis commenced early the next morning and she underwent dialysis on a total of six days after that until her discharge on 21 February 1995.

Although Abbey appears to have made a good recovery from her illness, her mother reports some behavioural problems, particularly hyperactivity and aggressive behaviour (T.541).

Jasmine, aged almost three years, ate one slice of Garibaldi plain mettwurst in mid January 1995, approximately one week before her mother heard the publicity about Garibaldi (which commenced on Monday 23 January 1995). Ms. Munn had purchased the mettwurst from the Foodland Supermarket at North Adelaide (T.485).

Jasmine's symptoms did not appear until Tuesday 14 February 1995, when she developed diarrhoea (T.488). The usual incubation period for "direct contact" cases was between 1 - 15 days, so the delay between consumption and onset of symptoms in this case suggests that this may have been a "secondary contact" or "second-wave" case. The following day, Jasmine was taken to a doctor at Norwood who suggested that her fluids be kept up, but her symptoms progressed until Friday 17 February, when she had developed abdominal pain and diarrhoea with a particularly offensive smell. She contacted the doctor again, who repeated his earlier advice.

By Saturday 18 February, Jasmine had begun vomiting and Ms. Munn, who was in Barmera at that stage, took Jasmine to the Barmera Hospital, where she was again advised to keep up the fluids and to try and obtain a urine sample. They returned to Adelaide on Sunday 19 February, by which time Jasmine had become lethargic and was no longer urinating. She took Jasmine to the WCH where she was admitted and placed on a drip. Tests were taken and by Monday 20 February 1995 a diagnosis of HUS was made (T.497). Jasmine was catheterised that day and dialysis commenced and continued on a further five days until she was discharged on 5 March 1995.

Jasmine continued to attend the HUS clinic weekly after discharge. This was progressively reduced. Apart from continuing nightmares, Jasmine appears to have made a full recovery (T.498).

The cases of Abbey Hamblyn, Dylan Paterson and Jasmine Munn-McDonnell probably constitute what Dr. Paton described as "second wave" cases in that there is no evidence of direct exposure to the contaminated product, but the organisms isolated from their faeces were indistinguishable from those associated with the children who had eaten contaminated product (T.1637-8). There is therefore no reason, on that basis, to exclude them from the list.

5. OTHER PATIENTS

I will now describe the cases of several patients who developed illness apparently after consuming Garibaldi products, although several did not progress to develop HUS or TTP. The relevance of this evidence is that it discloses the sequence of events taking place during the epidemic, and the extent of the illness which resulted. As I mentioned at the outset, however, more than 150 cases made up the eventual SAHC database.

David, aged nine years, first displayed symptoms of diarrhoea, vomiting and hallucinations on 4 January 1995. His mother had purchased Garibaldi garlic mettwurst and salami on 28 December 1994 and had prepared a number of home-made pizzas which she then froze. These were to be used by David and his elder sisters while their parents went trekking in Nepal. David proceeded to eat several of these pizzas in early January of 1995. A sample of the mettwurst was handed to an officer of the SAHC on 25 January 1995.

David's illness was initially diagnosed as "gastro" and he was seen on successive days at the Morphettville Medical Centre until Saturday 7 January, when he was admitted to WCH and placed on a drip as he was dehydrated.

He was discharged on Wednesday 11 January 1995 and did not require dialysis.

Steven, aged twelve years, consumed mettwurst in sandwiches on Sunday 22 January 1995 and on successive days until 26 January. His mother had purchased Garibaldi Garlic Mettwurst on Friday 20 January 1995 from Con's Fine Foods at the Central Market.

She heard the Acting Minister's announcement on 23 January, checked the use-by date and found it to be 5 April 1995. Since the Acting Minister had only referred to product with a use-by date of 12 March, she decided that all was well and allowed her children to eat more from the same stick (T.850).

The first symptoms appeared on Saturday 28 January with stomach pain and diarrhoea. Steven was seen by general practitioners and locums on Saturday 28 and Sunday 29 and Monday 30 January, when a faecal specimen was delivered to the IMVS.

On Tuesday 31 January Steven was taken to the WCH but not admitted. His condition gradually improved, and he appears to have made a full recovery.

Mr. Body, aged 66 years, first noticed anal bleeding on Saturday 14 January 1995 (T.473). He had purchased Garibaldi garlic mettwurst from the Bi-Lo Supermarket at Kilburn on 13 January 1995 and on that day ate approximately 6 inches of the stick. The following day he developed abdominal pain and on Monday 16 January 1995 he consulted his general practitioner, Dr. Wicks, who referred him immediately to the Royal Adelaide Hospital (T.476). He was admitted to the hospital that day and placed on a drip, and samples were taken. His condition had improved by Saturday 21 January and so he was discharged on that day, whereupon he returned home and celebrated by eating a further 2½ inches of mettwurst from the same stick. On Sunday 22 January 1995 his illness relapsed, the pain and diarrhoea returned and he noticed blood in his faeces. He said that he had discussed the fact that Garibaldi mettwurst was involved in an epidemic with his neighbour that day, and on checking discovered that the brand of mettwurst in his refrigerator was Garibaldi (T.472, 478). It is probable that Mr. Body is mistaken as to when this conversation took place, since the Acting Minister's announcement connecting Garibaldi mettwurst with the epidemic did not take place until Monday 23 January 1995.

On Monday 23 January 1995 Mr. Body returned to see Dr. Wicks, and gave what remained of the mettwurst stick to him (T.479). Dr. Wicks subsequently arranged for that sample to be provided to the IMVS and also advised Dr. Scott Cameron of the SAHC.

Mr. Body's condition improved without further hospitalisation, and he has made a full recovery.

Mrs. Spearman, aged 60 years, purchased a 750gm stick of Garibaldi garlic mettwurst from the Foodland Supermarket at Woodcroft on either 4 or 5 November 1994. She ate a couple of slices on Sunday 6 November and a few more on Monday 7 November 1994 (Exhibit C.85, p.2).

She developed bloody diarrhoea on Sunday 20 November 1994 and after seeing her general practitioner that day and on 22 November, she was referred to the Flinders Medical Centre where she was admitted. On Monday 28 November 1994 her condition deteriorated and she suffered seizures and heart failure, and was transferred to the Intensive Care Unit, where she remained until 6 December 1994. She was then transferred to the renal unit until her discharge. She did not undergo dialysis (T.2587).

Mrs. Spearman suffered a fractured sternum and three fractures of the thoracic spine from cardio-pulmonary resuscitation (C.85, p.3).

Following her discharge on 16 December 1994 she learned that she had been diagnosed as suffering from HUS (T.2583).

Mrs. Spearman appears to have made a good recovery from the HUS, but still has pain from the fractures, particularly in the spinal area. She continues to take medication to avoid blood-clotting.

A discharge summary from Flinders Medical Centre (Exhibit C.85a), discloses that Mrs. Spearman had a complex of illnesses when she was admitted, but a renal biopsy taken on 2 December 1994 disclosed that she had "Thrombotic Micro-angiopathy in keeping with Haemolytic Uraemic Syndrome" (see the histopathology report, Exhibit C.85b).

Assuming that Mrs. Spearman did have HUS, and also assuming that the Garibaldi garlic mettwurst was contaminated (there is no evidence of this since no sample was available for testing), the timing of her case is significant. She consumed the mettwurst on 6 November 1994, which means that it could have been manufactured several months earlier, and by October at the latest. Unfortunately, it is not possible to verify these facts now.

The other significant aspect of her case is that her illness does not appear to have been reported to SAHC (presumably because no link with food had been established). If it had been, then Michelle Vanderkop's case would have been the second, and Joshua Sadler's the third case. It is interesting to speculate about whether the epidemic would have surfaced earlier, had Mrs. Spearman's illness been reported in November (see later).

Mrs. McGovern, aged 69 years, purchased Garibaldi garlic mettwurst from the Erindale Foodland Supermarket in early January 1995 (T.3054).

Although her memory was poor, no doubt due to the severity of the illness she had suffered (T.3047), Mrs. McGovern said that she ate the mettwurst about two or three days before she went to hospital. Unfortunately, no mettwurst was available for testing, as Mrs. McGovern's daughter, Mrs. Angela Newbound, and her husband cleaned out Mrs. McGovern's refrigerator on Friday 20 January 1995 (T.594).

On Monday 16 January 1995, Mrs. McGovern developed diarrhoea which worsened over the next few days. She began vomiting, and her daughter later discovered that she had also bloody diarrhoea (Exhibit C.28, p.2). On Thursday 19 January, Mrs. McGovern was taken to the Royal Adelaide Hospital by ambulance, which had been called by a neighbour (T.3050).

Mrs. Newbound said that she had been told by the doctors that her mother had contracted TTP (T.592).

Mrs. McGovern underwent dialysis at the Royal Adelaide Hospital for a period of about five weeks (T.593), and remained in hospital for a total of 13 weeks. When discharged from hospital in April 1995, she remained tired and weak, requiring the use of a walking stick to get around. Prior to her illness, she was an active lawn bowler, although she had not played competitively for a few years (T.3051).

Mrs. Vermeer, aged 57 years, purchased a packet of sliced garlic mettwurst from the deli section at Woolworths Supermarket, Victor Harbor, on Wednesday 4 January 1995. She purchased another two packets of Garibaldi mettwurst from the same venue on Wednesday 18 January 1995 (T.1159). Understandably, she is unable to identify the date or dates upon which she ate the mettwurst, but it was somewhere between 4 and 31 January 1995.

On Tuesday 31 January 1995 Mrs. Vermeer developed symptoms of shivering and nausea, which persisted until Sunday 5 February when she developed stomach cramps and was unable to eat. She began vomiting on Monday 6 and Tuesday 7 February and developed diarrhoea on Wednesday 8 February. On Thursday 9 February she attended upon Dr. Odee, but he suggested that her illness was viral in origin and that it would pass in a couple of days (T.1163).

By Sunday 12 February Mrs. Vermeer's condition had not abated, so after contacting Dr. Wildman she attended at the South Coast Hospital at Victor Harbor, where she was admitted and placed on a drip, and blood and urine were sampled for testing. She was conveyed to the Flinders Medical Centre by ambulance that afternoon, when she was admitted and remained in hospital until 16 February 1995. While in Flinders Medical Centre, she was told that her illness had been diagnosed as HUS, although she said that she was never informed that her illness related to Garibaldi products (T.1165).

Mr. Hudson, aged 49 years, and already a sufferer from Brights disease, a disease of the kidneys, purchased Garibaldi garlic mettwurst from the Foodland Supermarket at Hope Valley in mid January 1995 (T.603). On either 24 or 25 January he ate a slice of the mettwurst, about 1½ to 2 inches thick. He said that he had eaten some from the same stick a week or so prior to that date (T.605-6).

On or about Thursday 26 January 1995 he developed symptoms of nausea and dry vomiting. On Friday 27 January he heard on the radio about a connection between mettwurst and the current epidemic (T.611).

On Friday 3 February he attended upon a general practitioner when a diagnosis of giardiasis was made. The doctor prescribed Flagyl, an antibiotic, for the condition (T.612).

Mr. Hudson felt reasonably well until Tuesday 7 February 1995 when he attended upon Dr. Bannister at the Modbury Hospital in connection with his existing kidney complaint and told him of his consumption of Garibaldi mettwurst. He was examined and a blood sample was taken on that day. On the following day he was contacted by Dr. Bannister and advised that his kidneys were deteriorating and that he should attend at the Royal Adelaide Hospital (T.613). On Thursday 9 February 1995 he was admitted to the Royal Adelaide Hospital for further tests and remained there until Saturday 11 February, when he was discharged. On Tuesday 14 February he was admitted to St. Andrews Hospital where he underwent dialysis and was discharged on Friday 17 February.

Following his discharge, he was advised that the faecal specimens were negative for E.Coli.0111 (T.623).

Mr. Hudson has been informed that he will require ongoing dialysis for the rest of his life unless a transplanted kidney becomes available. However, he very fairly conceded that he may have required dialysis in any event because of his pre-existing kidney condition (T.615), and this is consistent with the opinion of Dr. Bannister, his nephrologist (see Exhibit C.224).

Mr. Mattschoss ate Garibaldi mettwurst shortly before Christmas 1994 and died on 29 December 1994. According to Mrs. Caroline Walker of SAHC, the case was reported to them by the son of the deceased, and Ms. Manatakis interviewed Mrs. Mattschoss on 5 February 1995 as part of her general epidemiological investigation. Although there is a history of consumption of Garibaldi mettwurst, the evidence is insufficient at this stage to form a conclusion that Mr. Mattschoss died of HUS or TTP. This may be the subject of a separate inquiry.

6. BACKGROUND - PREVIOUS INFORMATION AVAILABLE

A number of incidents which occurred prior to the HUS epidemic in 1995 were examined during the inquest. The relevance of these incidents was that they demonstrated the degree of information which was available to Garibaldi, particularly since 1991, upon which they could have rectified any deficiencies in their manufacturing processes, and which was also available to the SAHC and which could have influenced their actions in relation to the outbreak.

(a) The Tibaldi Outbreak - 1982

Although this incident was not examined during the inquest, it is pertinent to point out that it was the evidence of Mr. Lou Marchi, the Managing Director of Garibaldi, that he was previously associated with Tibaldi Smallgoods Pty. Ltd. He commenced working with Tibaldi in Melbourne 30 years ago, and then transferred to Adelaide as its regional manager. In 1971 he set up a new business known as L & M Smallgoods, with his partner, Mario Vallorani. This later became Garibaldi Smallgoods Pty. Ltd. (Exhibit C.155, p.3).

He was obviously aware of the outbreak of salmonella involving Tibaldi since he said in evidence that Garibaldi first experimented with the use of starter cultures following that particular outbreak (T.5128). It is reasonable to conclude that, even at that stage, it was well-known that the use of starter cultures could assist with quality control of a fermented product.

(b) The Gallichio wedding - 1991

On 16 February 1991, up to 100 guests at a wedding reception became ill with food poisoning. Subsequent tests disclosed that the source of the illness was Salmonella Anatum, which organism was later isolated from salami products obtained both from the caterer, Mr. Blefari, and from Garibaldi itself. A particular type of salami known as "Casalingo" was identified as the culprit. An order pursuant to Section 25 of the Food Act was made prohibiting movement of that particular product.

A conference took place on 8 March 1991 to discuss the ramifications of this incident. Present were representatives of the SAHC (Dr. Cameron, Messrs. Hayter, Baldwin, Darke and Turner, and Ms. Tiller), Mr. Chris Murray from the IMVS, Mr. Lou Marchi and Mr. Neville Mead from Garibaldi, Messrs. Stevens and Neale from the Meat Hygiene Authority, and Mr. Baker from the Woodville Council.

A note of that meeting (Exhibit C.93a) discloses that the following matters were discussed:-

· Chris Murray pointed out that the presence of salmonella in a food product was a breach of the Food Standard;

 

· Lou Marchi admitted that the Casalingo salami was sometimes released with as little as two weeks maturation time, instead of the usual six weeks;

 

· Lou Marchi also admitted that there was no batch code on each individual salami;

 

· although Garibaldi was using starter culture at that stage, they were not using acidulant (GDL);

 

· Chris Murray informed Garibaldi that there was a salmonella risk with salami and regular testing of the product may be useful;

 

· Lou Marchi indicated that they were in the process of setting up their own laboratory;

 

· Chris Murray indicated that it "would be best to tackle the problem with quality assurance procedure - if end-product specifications consistently met there would be no problem.";

 

· Chris Murray asked Lou Marchi "are you checking pH drop after 24 hours?", to which he replied "no". Dr. Cameron then said, "it's a simple test - it's a very critical time the first 24 hours.";

 

· Neville Mead admitted that there was no date coding on the product.

 

Of particular importance to this inquiry was that the directors of Garibaldi were warned in 1991 of the necessity for a quality assurance procedure, and the fact that it was critical to measure the pH drop in the first 24 hours.

On 14 March 1991 Peter Hobson of the SA Health Commission attended at the Garibaldi factory and spoke to Neville Mead.

Mr. Mead answered some previously prepared questions. Mr. Hobson's note is as follows:-

Q: "What are the proposals for future product quality control?

A: . we will be improving manufacturing techniques;

. tighter controls;

. testing of products - by IMVS or by their own laboratory - including testing for salmonella, pH, fat content, moisture, etc.".

 

There was no prosecution of either the company or any of the directors in relation to this outbreak, either in relation to the presence of salmonella in its food product, or in relation to the lack of appropriate labelling from which it might have been possible to have identified the particular date of manufacture. What is particularly remarkable about this incident, is that the SAHC officials were fully aware of the fact that Garibaldi could not trace the raw materials that went into the contaminated salami at that stage, and yet no mention appears to have been made by anyone concerned of the need for them to attend to this.

Even if they had not been prosecuted, one might have thought that the Health Commission would have advised or warned Garibaldi that they were in breach of the code by their inability to identify the date of production.

Had they done so, and Garibaldi complied, the date of production of the contaminated mettwurst in 1995 might have been ascertained, the particular source meat which caused the contamination could then have been traced, and the investigation would have been made easier and more effective.

Further, the Health Commission seems to have accepted the assurances of Mr. Mead and Mr. Marchi that they intended to address issues of quality control and upgrading of their processes. No-one from the Health Commission attended at the Garibaldi factory after this outbreak in 1991 to ensure that these undertakings were being carried out.

Another aspect of this matter is that it seemed clear that the problem with the Casalingo salami might well have related to the fact that it had been released without being fully matured. This also became a relevant issue in relation to the 1995 outbreak.

The extent to which the SAHC representatives should have learned from this experience is illustrated by an article written by Mr. Hobson and Dr. Cameron after the outbreak entitled "Salmonella anatum food-borne outbreak, South Australia" - in the publication known as "Communicable Diseases Intelligence", Volume 16, No. 5, 9 March 1992, which came to the following conclusions at p.98:-

· "the presence of a number of different salmonella serotypes in other batches of salami highlighted concerns with the manufacturer's processing procedures and quality control practices";

 

· "a possible cause for the presence of salmonella in fermented sausage is the use of contaminated meat. The lactic acid fermentation process acts to destroy pathogens present, but survival and growth of these organisms might be expected in the event of a weak lactic acid fermentation. The manufacturer was advised to implement a quality control programme to ensure the safety of the product prior to its release for sale for human consumption".

 

At p.95, the article suggested:-

"Environmental health officers from the SAHC and local authority conducted a thorough inspection of the manufacturer's premises, resulting in recommendations being made on processing procedures, general hygiene, product batch identification, labelling, and storage"

(my underlining - See Exhibit C.80EE).

The evidence from those who participated in the inquiry indicates that the last assertion was in fact untrue. I have been unable to find any evidence that the subject of product batch identification, labelling, and storage was the subject of a recommendation at that time.

(c) The Pisani outbreak

In July 1992 the SAHC investigated an incident of food poisoning involving the Pisani family from Port Pirie. Mrs. Pisani and three of her grandchildren ate Garibaldi salami and all became infected by Salmonella Agona type 2. The initial epidemiological investigation, if it could be described as such, was left to the local Environmental Health Officer (EHO) attached to the Port Pirie Council. The mother of the children obtained the salami sample and provided it to the EHO. This was then submitted to the IMVS at Port Pirie, and then forwarded to Adelaide. It was analysed and found to be heavily contaminated with Salmonella Agona type 2 organisms. In Adelaide, the SAHC established that the supplier of the particular salami purchased was Garibaldi smallgoods. Samples of salami, purchased on 24 August 1992 by SAHC officers, and subsequently tested, found no salmonella present.

At a meeting on 26 August 1992 at the SAHC premises, during which Garibaldi was represented by Mr. Lou Marchi, Mr. Phil Marchi and Mr. Neville Mead, Mr. Mead indicated that it was difficult to identify the sample as theirs.

Consideration was given to a prosecution of Garibaldi arising out of this incident (see the report of Mr. Hobson dated 23 October 1992, Exhibit C.80f), but the prosecution did not take place because the salami sample, which had proved positive for the presence of salmonella, had passed through so many hands that it was impossible to prove a chain of evidence sufficient for a prosecution. On the advice of the Crown Solicitors Office, a prosecution was not attempted.

In the report I have already mentioned, Mr. Hobson made the following recommendations (at p.5):-

· a review needs to be conducted to establish whether or not the labelling practices adopted by Garibaldi in this matter were appropriate since Mr. Hobson identified that it was difficult to trace the product to the manufacturer in the absence of appropriate labelling;

 

· a protocol should have been developed in relation to the handling of food samples associated with food poisoning cases in order that a chain of evidence could be proved in court.

 

Again, it seems extraordinary that no follow-up took place with Garibaldi, particularly in relation to the labelling issue, which has proved most unfortunate in view of the difficulties involved in the investigation of the 1995 outbreak.

In evidence, Lou Marchi denied that the Pisani sample of salami was Garibaldi's (T.5183), and Neville Mead took the approach that it had not been proven that it was their product (T.5291-3).

Leaving aside the fact that the SAHC were unable to prosecute Garibaldi, since this was the second time within the space of twelve months or so that the company had been the subject of an inquiry as the result of a contaminated fermented meat product, it seems extraordinary that the company did not take more energetic steps to implement the quality control procedures as they had promised to do in 1991.

It is just as extraordinary that there were no further visits by SAHC in which they sought to verify that the company had fulfilled their promises in the ensuing three years.

(d) Dr. Andrews' research

Dr. Stuart Andrews is a lecturer in applied microbiology at the University of South Australia, School of Chemical Technology. He holds a Ph.D. in microbial biochemistry. A company called Techsearch is the "commercial arm" of the University and contracts with outside clients for the purpose of providing university staff as consultants. It was in this capacity that Dr. Andrews carried out periodic consultant work for the Garibaldi company from 1991 to 1995.

Dr. Andrews also taught Mr. Philip Marchi in an Advanced Science Technician's Certificate course with an option in microbiology at the University. Dr. Andrews explained:-

"I think it's important to appreciate that this was a technician's training course, so the course was really designed to teach people techniques to work in a laboratory to do analysis of food products and other products. So the level of teaching was more on techniques, rather than on academic development of the subject ... (but) ... because there were only two students, and they were both working in the food industry, I decided to take them through some concepts of food microbiology, and we talked about some of these concepts".

(T.3520).

I should say at the outset that I found Dr. Andrews to be an impressive witness. He was a patently honest witness who presented his evidence in a forthright and unambiguous way. Even though his role was to assist Garibaldi right up until the time that the situation was irretrievable in late January of 1995, he retained an objectivity and honesty which was commendable.

In June 1991 Dr. Andrews conducted some tests into starter cultures at the request of the company. It seems clear that this investigation was prompted by the Gallichio wedding outbreak. The results of Dr. Andrews' investigation were that the two starter cultures provided were suitable for the purpose of fermenting salami, and he recommended that further information be obtained from the suppliers to verify his findings about the utility of the two products tested (see his report, Exhibit C.99a).

When being questioned about the decision made by Garibaldi to discontinue the use of starter cultures, Philip Marchi said that one factor in the decision was the difficulty of obtaining proper technical specifications about the product. This seems difficult to reconcile with the contents of Dr. Andrews' report since it contains all the technical specifications which the company should have needed. One would have thought that had they had difficulty in getting further technical information for the company, a simple expedient might have been to contact Dr. Andrews again. They apparently did not do so (T.3475).

In a report dated 26 June 1992 (Exhibit C.99c), Dr. Andrews carried out a microbiological analysis on a number of Garibaldi smallgoods products. The introduction to the report suggests that the report was stimulated by the demand by purchasers of smallgoods for chemical and microbiological specifications.

Philip Marchi actually participated in this research, under the supervision of a graduate, in some of the "hands-on testing", although he was not involved in any of the interpretation or report-writing (T.3522).

Of particular interest is the fact that Dr. Andrews conducted a comparison between samples of mettwurst manufactured with and without starter culture. Significant matters which emerged from his investigations are as follows:-

· mettwurst produced without starter culture displayed a higher average pH, indicating that less acid had been produced, and much higher coliform counts. Dr. Andrews warned that he did not know the initial rate of acid production, although he speculated that it was slower having regard to the higher coliform counts. He said:-

"In the fermentations that do not use an inoculum the coliforms and E.Coli can become more readily established if the rate of acid production is not rapid. Once established they are difficult to control. Theoretically if the coliforms can grow, so can salmonella if present on the raw meats."

(Exhibit C.99c, p.14);

· even in products with starter culture, the moisture content of the mettwurst varied enormously from between 34% and 50%. Additionally, the coliform counts also varied enormously from as low as five per gram to greater than 18,000 per gram. He commented:-

"In theory as the fermentation proceeds, the rapid acid build-up should suppress the growth of coliform, E.Coli and salmonella, but it appears that in many cases the rate of acid build-up or level of acid developed were insufficient to kill the coliforms and related enteric bacteria."

(Exhibit C.99c, p.12).

Dr. Andrews had been asked to prepare "specifications" for mettwurst, no doubt so that these could be supplied to Garibaldi customers. These specifications are really the quality parameters, including pH, moisture content, and the concentrations of bacteria, yeasts, moulds, etc., which might be found in the product. The customers would either find the ranges specified acceptable, or choose to specify a more stringent range, in which case Garibaldi would then be challenged to produce an even better product.

At the end of his research, Dr. Andrews found himself unable to prepare specifications in relation to Garibaldi's mettwurst. He outlined some possible guidelines which Garibaldi might aim at, but indicated that only five out of the seventeen samples they had submitted to him were capable of meeting the specifications.

Dr. Andrews made the following comments, at p.16:-

· "In terms of quality management, I believe that all fermented sausages should be inoculated with a starter culture of known viability. I don't believe that you can assure quality by letting the natural microflora develop on fermented sausages and then meet specifications for your purchasers.";

 

· "Of concern is the wide range of values obtained for moistures and coliforms. If specifications for products are to be developed, there will need to be a lot more control over the fermentation process to produce a more consistent product".

 

Dr. Andrews made the following recommendations, which he said needed to be considered urgently (see Exhibit C.99c, p.17-18):-

1. "Closer process control is essential. In particular the wide variation in water content is of great concern ...".

He suggested that the company might consider the purchase of a machine for testing water activity, or consider partially funding the purchase of such an instrument to be housed at the university, to which the company could have access. Neither suggestion was adopted by Garibaldi.

 

2. The rate of drop in the pH of the product should be monitored in the first 24 to 48 hours for the purpose of drawing specifications for the rate of pH drop. He commented:-

"After a comprehensive investigation monitoring the initial rate of pH decrease with the final level of coliform and salmonella in the product at a specific maturation date, it should be possible to specify the critical pH that the product should reach within the number of hours from the start of fermentation".

The concentrations of sodium chloride and nitrite ions should also be measured as an additional parameter to the measurement of water activity.

 

3. After those investigations have been carried out, a repeat survey should be performed to determine realistic specifications for the product.

 

Although Dr. Andrews gave evidence that he discussed these recommendations with both Philip Marchi and Neville Mead (T.3534-3538), he said that Neville Mead told him that the further work he recommended in relation to quality control could not be done because the company could not afford it (T.3538). Lou Marchi also told Dr. Andrews that although he could see the merits of his recommendations, Marchi had been making mettwurst and salami for many years without a problem (T.3538).

Despite Dr. Andrews' attempts to convince the Garibaldi directors to invest in a comprehensive quality assurance programme throughout 1992, they did not do so (T.3539).

Perhaps ironically, the one development which did take place after Dr. Andrews' research was that the company discontinued using starter culture, in direct contradiction of his recommendation.

Lou Marchi said that he did not really read Dr. Andrews' report thoroughly, but he agreed that he had discussed it. He conceded that he may not have taken Dr. Andrews' recommendations seriously enough (T.5025-8, 5148).

Neville Mead agreed that although the company attempted to carry out Dr. Andrews' recommendations incrementally, a comprehensive quality programme had to be postponed until the company was in a better financial position (T.5291).

What is remarkable about this aspect of the matter is that I am not convinced, even now, that Lou Marchi, Philip Marchi and Neville Mead have a clear idea of what a quality assurance programme means. They seemed to think it simply referred to checking to see that everything was clean, making sure that the source meat was fresh and appropriate, and monitoring temperature, humidity, etc. What they do not appear to have grasped is that these parameters must be checked against pre-set control criteria so that any deviance will indicate a problem with the process (see, for example, the evidence of Philip Marchi at T.5497). In order to assure quality, "critical control points" need to be identified and then procedures set up to monitor them. It is the monitoring of these factors, and taking action to remedy anything that such monitoring indicates is amiss, which constitutes quality assurance.

(e) Codes of Practice and Legislation

Various codes of practice and other publications have outlined criteria for hygienic and appropriate smallgoods production and encouraged the adoption of quality assurance procedures.

As far back as December 1982, the National Smallgoods Council of the Meat and Allied Trades Federation of Australia ("MATFA") prepared a publication called "Code of Practice for the Hygienic Manufacture of Dry and Semi-Dry Sausage" (see Exhibit C.72). The introduction to the publication includes the following statement:-

"The adoption by members of practices outlined in this and other guidelines in this series should help to overcome any production faults and, through good hygiene and quality control measures, ensure the output of quality meat products, improved shelf life, and enhanced product reputation".

 

Relevant to this inquiry, the code included the following recommendations:-

· rapid acidification should be assured through the use of an active starter culture and/or chemical acidulant (e.g. glucono delta lactone) to inhibit the growth of staphylococci and other food poisoning organisms in the fermenting sausage (paragraph 8(b) );

 

· pH measurements should be utilised to ensure that the process achieves a pH of 5.2 within 48 hours (paragraph 8(c) );

 

· the microbiological status of the fermented sausage during production should be routinely checked (paragraph 9);

 

· fermentation and maturation periods should be recorded. These periods will be set by the requirements of the final product specifications (paragraph 10);

 

· recall of a particular lot of a consumer product is not possible unless all packages for retail sales are marked with a legible batch code (paragraph 11);

 

· records, adequate to identify the processing history of each batch, should be retained for suitable periods of time (paragraph 12);

 

· an adequate recall procedure should be established and registered with the appropriate authority (paragraph 13).

 

Although Philip Marchi was a committee member of the National Smallgoods Council, he said that he had never seen the 1982 document (T.5482).

More recently, in 1992, a further code was promulgated by the MATFA. This code was based upon a document entitled "Guidelines for Good Manufacturing Practices for the Smallgoods Industry" prepared by the Australian Quarantine and Inspection Service of the Department of Primary Industry and Energy ("AQIS"). In the introduction to the 1992 document, MATFA drew attention of members to the Food Standards Regulations : Standard C.1 - Meat and Meat Products, as containing the regulatory requirements for smallgoods. The 1992 document was more detailed than the 1982 one, but was basically similar in approach.

Significantly, the 1992 document recommends the establishment of a haz