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 hazard analysis critical control point ("HACCP") programme. A HACCP programme involves listing all the major and minor steps in the process, classifying those steps into various categories, and depicting the entire process on a flow chart. Critical control points are then identified as being those points in the process which must be controlled to avoid unacceptable food safety risk. Of course to ensure control, those critical control points must be monitored, and corrective action taken should the limits or parameters set for each point not be met. For example, reverting to Dr. Andrews' recommendations for the establishment of specifications for mettwurst production, critical control points might include pH levels after 24 and 48 hours, and water activity levels after given periods. The flow chart should depict the stages in the process where those control points exist, and the methods of monitoring same and specify corrective action to be taken should the criteria not be met.

Philip Marchi, who as I said, was a committee member of the National Smallgoods Council, was not sure whether he had seen the 1992 document (T.5484).

Other documentation which was available to Garibaldi included such publications as the Meat Research Newsletter produced by the CSIRO Division of Food Processing (Meat Research Laboratory) of which Dr. Grau is a senior officer. An example of the newsletter dated 7 August 1992, carries an article entitled "Recommendations for the Production of Fermented Sausages", which contains detailed yet easy-to-understand information for the assistance of those involved in the smallgoods industry.

(f) Conclusion

Taking all of this material into account, including the information obtained through the Gallichio wedding outbreak and the Pisani outbreak, the research of Dr. Andrews during 1991-95, the availability of publications such as that issued by MATFA, AQIS and the CSIRO, I conclude that there was no excuse for any of the directors of Garibaldi to be ignorant of modern requirements for the safe and effective production of smallgoods. All of that evidence led to the conclusion that any conscientious manufacturer had a clear responsibility to establish a quality assurance or HACCP programme, and the putting in place of appropriate monitoring procedures to ensure that its product was meeting those specifications. In the absence of such a programme, it is not surprising that Garibaldi were unaware that its products, being cheerfully and aggressively marketed into the South Australian food chain, were contaminated.

The Managing Director of Garibaldi, Lou Marchi, complained that it was "disgusting" that the Company had not been warned about the dangers of E.Coli, as distinct from salmonella and other pathogenic organisms (T.4989). Apart from the fact that, from the point of view of a properly constituted quality assurance programme, there is no relevant distinction between the two organisms, the material referred to in this section clearly indicates that the directors of the company had ample information on the topic, particularly from Dr. Andrews.

7. THE MANUFACTURING PROCESS

(a) Source meats

I agree with the submission of counsel assisting me at the inquest, Mr. Bell, that the evidence of all the experts, particularly Dr. Paton, suggests that raw meat used in the manufacture of mettwurst was by far the most likely source of contamination (see Dr. Paton's evidence at T.1548).

The contamination of source meat may take place in a variety of ways. The organism is transferred from animal to animal via the faeces. Animals grazing in the same paddock are therefore likely to cross-infect each other with the organism. The cross-infection may also occur from carcass to carcass during slaughtering and boning processes, or indeed during transport if the carcasses are in contact with each other. The presence of shiga-like toxins on raw meat is far more prevalent than is generally realised. Dr. Mary Barton, the Manager of the laboratory known as Vetlab, which is now part of the Department of Primary Industries, and who, as part of a very impressive list of qualifications, is a specialist veterinary microbiologist, gave evidence that of the samples she examined, 15 out of 28 beef samples, 6 out of 20 pork samples, and 21 out of 25 lamb samples were PCR-positive on testing (T.3325-6).

Other research conducted both in Australia and overseas has indicated that the percentage of raw meat which may be contaminated with SLTEC-producing E.Coli could be as high as between 30% and 60% (T.3298).

Dr. Frederick Grau, a research microbiologist with the CSIRO, Division of Food Science and Technology in Brisbane, and an acknowledged authority in the area of food microbiology, particularly in relation to meat, explained the process by which E.Coli might be found in raw meat as follows:-

(see Exhibit C.160, p.1-2).

This contamination is usually on the surface of the meat and does not tend to penetrate deep into the tissue. Accordingly, cooking of the meat, even to a moderate degree, is usually sufficient to kill the organism. However, when raw meat is minced or diced, the organism becomes distributed throughout the sample and becomes more difficult to eradicate. An example of this difficulty has been encountered in the United States of America, where there have been several outbreaks involving the sale of under-cooked hamburgers (see the evidence of Dr. Paton at T.1748).

The batch production records, which were eventually produced by Garibaldi to the Health Commission, indicate that mettwurst was made using frozen mutton, fresh mutton, beef, and frozen pork back fat (see the records, Exhibit C.67b, and also the Standard Operating Procedures, Exhibit C.117b). Salami, on the other hand, was made with pork, and does not contain mutton.

Garibaldi obtained its meat from a variety of sources for use in its production. One reason why Garibaldi focused on the Victorian meat processor, MCS, was that it began using MCS meat in around November 1994, the time when the mettwurst with the use-by date of 12 March 1995 was produced.

Although frozen mutton was boned by MCS, it was slaughtered at abattoirs elsewhere in Victoria and transported to MCS for boning. Fresh mutton, beef and pork was slaughtered at various abattoirs in South Australia, and purchased by Garibaldi in whole carcasses and boned on the premises. Some fresh mutton was boned and supplied by other companies in South Australia, including Edwardstown Meat and P & D Export.

Any of the above meat could have been the source of E.Coli.0111. Samples of meat sent to the IMVS for testing by Garibaldi displayed PCR-positive results in relation to meat from MCS, P & D Export, and Beef and Lamb. A number of samples of raw meat which were tested during the course of the investigation, including mutton, pork and beef, also produced PCR positive results (see the table in Exhibit C.91b).

The management of Garibaldi, particularly Lou Marchi, still blames MCS meat as the source of contamination (see T.5077). The evidence is that only frozen mutton was obtained from that company. In view of the fact that Mr. Mead was, by 26 January 1995, aware that salami as well as mettwurst was contaminated (and mutton was not used in salami), and that he was also aware from Dr. Barton that various other types of meat commonly proved PCR positive, I agree with Mr. Bell that it is both illogical and unfair to single out MCS as the source of the contamination.

MCS meat was the subject of microbiological testing in Victoria by two separate agencies. This testing process produced quite contradictory results.

Mr. Gavan Murphy, a microbiologist employed by Centaur Industries of Benalla, carried out testing of mutton trunks which carried a date around the end of November 1994. In his statement, Exhibit C.98, Mr. Murphy said:-

"As a result of the testing, no escherichia coli.0111 was tested in any of the samples." (p.4).

 

It is relevant to point out that although Mr. Murphy informed Dr. Crossing, of the Victorian Meat Authority, that he had the capability of carrying out PCR testing on the samples, he was not requested to do so (T.3423). Mr. Murphy's results are unlikely to be particularly useful, since although the bacterial culture that he undertook in relation to many of the samples indicated a high coliform count (some in the hundreds of thousands per gram and several in the millions), he only picked off eight colonies from each sample for testing. I have already described how many, sometimes thousands were picked off in the course of testing in Dr. Paton's laboratory. It is therefore, perhaps, not surprising that he found no E.Coli.0111 in any of the samples he looked at.

Additionally, the counting technique adopted by Mr. Murphy was specified in his report as "performed as per AS1766.2.3 - Pour Method". Both Mr. Chris Murray from the IMVS, and Mr. Dario Comar from Microtech, indicated that the method referred to is not a method of counting E.Coli, it is merely a method of counting coliform bacteria, and hence would not have been appropriate to ascertain the presence of E.Coli in any event (T.4784).

Microtech, a microbiological and chemical consulting organisation, also carried out a microbiological analysis of frozen meat for MCS. It should be pointed out that although they tested similar samples, they did not test the same samples and accordingly a direct comparison of results is not really appropriate. The results can be summarised by saying that the level of coliforms found by Microtech was very much lower than that found by Centaur, the highest of such readings being 460 coliforms per gram (compared to millions found by Centaur).

Neither laboratory detected the presence of E.Coli.0111, but of course no PCR testing was done by either organisation.

In summary, there is no evidence from which one could conclude that the meat from MCS was contaminated to any greater or lesser extent than any other meat which may have been available to Garibaldi for its meat processing operations.

One conclusion which must be drawn from this evidence is that any manufacturer involved in meat processing must assume that meat being used will contain pathogenic organisms. This was the evidence of both of the experts in the area, Dr. Grau and Professor Baumgartner. Dr. Grau said (at T.5670):-

"Anyone who is handling food has to always assume the possibility of there being a pathogen on it and the processes they use have to be such as to take care of that possibility, because there is no way of guaranteeing that a pathogen is not present in low numbers".

 

In this case, the evidence is clear that Garibaldi's batch production records do not make it possible to identify the day on which a particular stick of mettwurst was made. Accordingly, it is not possible to identify the source of the meat which made up any particular stick. Mr. Mead admitted as much (T.5287).

In those circumstances, there was no point in entering into an examination of the meat inspection system as it exists in Australia at the present time and whether, if that inspection system was different, the risk of contamination would have been reduced. I must say that the results of the surveys conducted by Dr. Barton to which I have already referred, in which she indicated that 30% to 60% of samples displayed PCR positive results, are surprising, and that is a matter which will no doubt be the subject of consideration by those whose responsibility it is to govern the meat industry in this country.

There was a considerable degree of evidence about the standard of meat which was used by Garibaldi in its day to day operations. This was particularly the case in relation to fresh meat boned on Garibaldi's premises. The main evidence which is critical of Garibaldi in that regard came from Mr. John Gilbert, a former employee of the company. Mr. Gilbert gave highly coloured evidence about the poor condition of pork which he was required to bone, particularly during a period in early 1994 when, as a result of an alleged over-supply, 80 pork carcasses were left in the chiller for too long and were in a green and slimy condition by the time they were boned (T.3881). Other evidence critical of Garibaldi's methods came from Mr. Paolo Carna, who said that on at least twelve occasions he opened boxes of mutton which had been frozen, and left overnight to thaw, and found the meat was green (T.3739). He also alleged that this happened in relation to beef on two occasions. However, it was his evidence that this meat was not used for mettwurst or salami to his knowledge, but that it was used for what is known as salami cotto, a product which is emulsified and then cooked and used for pizza toppings (T.3762).

A number of other witnesses also gave evidence about the meat used by Garibaldi, and there was a bewildering variety of evidence on this topic. Mr. Gilbert and Mr. Carna were at one extreme, and Mr. Nowak, the foreman, was at the other (T.4195). Peter Vallorani (T.4049), Lou Marchi (T.5106) and Nowak (T.4194) all said that if any meat showed signs of being unsuitable, it was sent back to the supplier.

I must say that I found the discrepancies between the witnesses on this topic to be confusing and unconvincing either way. Mr. Gilbert's evidence seemed highly coloured and somewhat exaggerated, and he painted a picture of the premises which depicted the factory as highly unsanitary and unprofessional. Mr. Nowak, on the other hand, impressed me as a careful and meticulous man who seemed somewhat offended by any suggestion of an unhygienic or unprofessional approach. There is also the evidence that the factory was the subject of an unannounced inspection by Qantas Catering Service on 23 May 1994, after which a positive report was provided (see letter from Qantas dated 16.6.94, Exhibit C.156b), and the evidence of Mr. Surrell, the Environmental Health Officer from the Corporation of Hindmarsh-Woodville, that the factory was "extremely well-maintained" (T.3725).

While I suspect that there was the occasional lapse in hygiene, as I am sure would be the case in any such processing facility, I am unable to make any finding that, in the general course of business, Garibaldi encouraged or even tolerated unhygienic practices in the general sense. Indeed, there was a considerable body of evidence that the Managing Director, Lou Marchi, was somewhat fanatical about the hygiene and would often castigate workers for lapses in that regard.

However, it must be said that Garibaldi had no system for quality control of the source meats it was using for its products. While Dr. Grau suggested that any heavily contaminated meat ought to be detected upon visual inspection (T.5709-10), he conceded that this would have been difficult in relation to frozen meat. Professor Baumgartner suggested that the temperature of source meat should be checked regularly and random microbiological testing should have been undertaken (T.5610, 5652). Professor Baumgartner also suggested that it was incumbent upon the processors to satisfy themselves that slaughtering and boning practices adopted by their suppliers were appropriate (T.5652). There was some evidence that some of the fresh pork carcasses received by Garibaldi were at a higher temperature than they should have been, but it remains an open question as to whether that was through poor processing practices at the abattoirs, or through the carcass having been transported in unrefrigerated trucks to the Garibaldi factory (see the evidence of Mr. Gilbert at T.3807, 3822). As I have already observed, there is a conflict in the evidence between Mr. Gilbert and Mr. Marchi on the question of whether any such meat was rejected by Garibaldi and sent back.

In any event, the inability to trace the source meat to a particular stick of finished mettwurst or salami product renders this evidence of only marginal value in the overall inquiry. It is not possible to conclude from the evidence as to when, for example, any such meat, even if it was in such poor condition, was used in the manufacture of mettwurst or salami. The closest one can come to a conclusion in that regard is to say that it could have been.

Whatever might have been the system for meat inspection which applies in this country, the present situation is that there are no standards in force as to an acceptable level for coliform or E.Coli contamination. The evidence given in this inquest makes it obvious that the establishment of any such standard would be a difficult process since, as I have already outlined, Dr. Paton has told me that as few as one SLTEC-producing organism may be enough to cause HUS. That being the case, the task of determining how many such organisms should be tolerated as being acceptable in a given sample of meat, if any one of them might be capable of producing such a deadly disease, is a vexing one.

As I have already outlined, Dr. Grau takes the view that any responsible manufacturer should proceed on the assumption that small concentrations of toxic organisms are present on any sample of meat with which they deal and that their processes should be equipped to cope with that eventuality. I consider that standards should be established, and any such standards should be set at a level below which a properly monitored and scientifically validated manufacturing process will be capable of eliminating all coliform bacteria. All of the experts agree that the PCR screening on raw meat samples for the purpose of ensuring these standards would not be useful, since it is so incredibly sensitive that its results would not be useful in this context (see the evidence of Dr. Barton at T.3330).

(b) Mettwurst production

Professor Paul Baumgartner, the Professor of Meat Science and Technology at the University of Western Sydney, Hawkesbury, described the process by which mettwurst is manufactured in his statement, Exhibit C.159.

A brief description of the process is as follows:-

(c) Use of starter culture

A starter culture is a set of micro-organisms which are used to start the fermentation process. If they are not used, then the speed and strength of the fermentation process will depend upon the microbiological "flora" already present on the meat. This naturally-occurring flora may or may not be of the correct type, and may or may not be present in sufficient concentrations to establish a vigorous fermentation process during which "good" and "bad" bacteria compete with each other for sustenance. A successful fermentation process involves the production of lactic and other organic acids in sufficient concentrations to lower the pH of the general mixture quickly enough to inhibit, injure and eventually destroy "bad" bacteria which may be proliferating in the mixture. This is the whole object of the fermentation process.

In modern times, health authorities have insisted upon the use of stainless steel containers during the manufacturing process. In older times, wooden vats were used and bacteria often permeated the wood and provided a built-in starter culture to commence the fermentation process. Unfortunately, some of those built-in organisms were also pathogenic, and hence were allowed to cross-contaminate each batch prepared in the vat.

Professor Baumgartner describes the function of starter cultures as follows:-

· it reduces the pH of the mixture by production of lactic acid. The amount of sugar added to the mixture, which acts as a carbohydrate source for the bacteria, will also help to determine the final pH of the product;

 

· it speeds the fermentation process which controls not only the appropriate flavour of the product but also achieves an appropriate level of acidity within an appropriate time;

 

· quality assurance is improved in the sense that much greater consistency of the product will be achieved;

 

· the successful acid production reduces the incidence of pathogenic organisms in the product;

 

· it reduces processing time, and hence assists the manufacturer to achieve consistency and quality control.

(see his report, Exhibit C.159, p.7).

The evidence is clear that in 1994 when the mettwurst which has been the subject of this inquiry was produced, the Garibaldi Company was not using starter culture (see the evidence of Philip Marchi at T.5491-2).

Lou Marchi gave evidence that the company began using starter cultures after the outbreak of salmonella involving Tibaldi products in 1981. However, his evidence was that they discontinued using starter cultures in 1988 or 1989, because they were uncertain about the quality of the starter cultures they were obtaining (T.5128). They commenced using starter cultures again in 1991, but they stopped again after a few months (T.5128). There is other evidence that Mr. Marchi is mistaken about this. At a meeting on 8 March 1991 Lou Marchi informed representatives of the Health Commission, IMVS and the Meat Hygiene Authority that they were using starter culture at that stage (see Exhibit C.93a, p.4). That much is consistent with his evidence. However, Dr. Stuart Andrews, the consultant microbiologist employed by Garibaldi, gave evidence that they were still using starter culture in November 1993 when he was carrying out a number of analyses (T.3586).

It would appear that the decision to discontinue use of starter cultures was made by Lou Marchi on the basis that he felt that there was little difference between products manufactured with and without starter culture, and that products made without it had a better colour and taste (T.4956). Philip Marchi gave evidence that he did not consider himself experienced enough to make the decision (T.5493), although he supported the decision. This is surprising in view of Philip Marchi's microbiological knowledge, and also in view of the various reports provided by Dr. Andrews. Mr. Marchi's evidence is also surprising in view of Professor Baumgartner's evidence that he had never heard of starter cultures causing a bitter taste in the product, although he had heard that in relation to GDL (acidulant) (T.5645).

The non-use of starter cultures in the production of mettwurst runs contrary to all of the expert opinions that I have heard during the course of this inquest. In his report of 26 June 1992, Dr. Andrews strongly advocated the use of starter culture in the interests of quality control (see Exhibit C.99c). Dr. Andrews denied that he had ever given Garibaldi advice which could be interpreted as approval of not using starter culture (T.3601).

Professor Baumgartner recommends the use of starter cultures, as I have already described (see T.5613), and Dr. Grau also advocates their use (T.5680).

The consensus of opinion is that without the use of a starter culture, the fermentation process is entirely unpredictable and unreliable, and it is impossible to ensure quality control without it.

Notwithstanding this preponderance of expert opinion, it is most surprising that a survey carried out by the SA Health Commission in 1994 indicated that only seven of 24 manufactures were using a starter culture, and only nine out of 24 were using an acidulant (T.2562). Despite Philip Marchi's protestations about the difficulties involved in getting specifications from the manufacturers of starter cultures as to their proper use and storage (T.5491), Professor Baumgartner, who was familiar with the particular manufacturer concerned, said that the company provided detailed specifications with their product (T.5616).

Mr. Wintulich, a competitor of Garibaldi who has also suffered severe financial loss as a result of this epidemic, but the quality of whose product has never been called into question, said that he had been using starter culture since 1980 (T.3355).

Since April 1985, an amendment to the Food Standards Code renders the use of starter cultures compulsory. It is to be hoped that those charged with the task of regulating the industry will be effective in ensuring that all manufacturers comply with this requirement at an early time. However, use of starter cultures will not, of itself, guarantee product quality. Its use is only one factor in an overall quality assurance programme.

(d) Monitoring of pH levels

I have already mentioned the fact that it is important that the pH of the mixture drops with appropriate rapidity so that a pathogenic organism is retarded, and then stopped, and that those which have already grown are eventually destroyed. There is clear evidence that the first 24 hours in this process is critical (see the evidence of Dr. Grau at T.5666).

Garibaldi was informed of this at the meeting following the Gallichio wedding salmonella outbreak (see Exhibit C.93a, p.4). The note of the meeting on 8 March 1991 discloses the following conversation taking place:-

Chris Murray (IMVS): (to Lou Marchi)

"Are you checking pH drop after 24 hours?"

Lou Marchi:

"A. No."

Scott Cameron (SA Health Commission):

"It is a simple test. It is a very critical time the first 24 hours".

 

Perhaps as a result of this conversation, Garibaldi had its pH meter repaired on 15 May 1991, but they had trouble getting the machine to work (T.5416). Another pH meter was purchased in October or November of 1992. Prior to that time, the company had not done any pH testing (T.5416).

Philip Marchi said that in early 1993 he did a thorough pH analysis of products produced at the factory at various stages during the process from 14 hours to eight days after fermentation. He said that he recorded these results, but in early 1995 he was unable to locate them (T.5471). It does not appear that the results formed the basis of any specifications for the product, however.

In 1994, Philip Marchi said that he conducted random tests for pH once or twice a week but no records were kept (T.5446). During the meeting on 27 January 1995, Philip Marchi informed Nick Rose from the Health Commission that random testing was being carried out (see T.1982).

However, contrary to this evidence, Dr. Stuart Andrews, the consultant retained by Garibaldi from 1992 to 1995, gave evidence that on 25 January 1995, that is two days after the Ministerial announcement, and during what might be described as a crisis at the company, the following conversation took place:-

"Q. Would you have had a discussion with them at that time about what the pH of the allegedly implicated products might have been?

A. I don't think they were actually measuring the pH of the product.

Q. What makes you say that.

A. I asked them what the pH.s of the products that they were manufacturing at the time were, and it was acknowledged that they hadn't been using the pH meter recently.

Q. About when was this conversation.

A. That conversation would have been on 25 January.

Q. Where did it take place.

A. At the site of the factory.

Q. Who told you that.

A. Philip Marchi."

(see T.3504).

Philip Marchi denied that he said that to Dr. Andrews, and insisted that he was still conducting random pH sampling on a weekly basis at that time (T.5446), although no records were kept.

I accept the evidence of Dr. Andrews in this regard in preference to that of Philip Marchi on the basis that he clearly has no motivation to mislead me on that topic and, indeed, came from the Garibaldi "camp" at the time the conversation occurred. I find that no pH testing was being carried out in the latter part of 1994 when the particular mettwurst that was the cause of this epidemic was manufactured.

(e) Industry practice

Evidence varied considerably as to the appropriate pH level to be achieved, and at what stage of the process. Although there is evidence that the initial 24 hour period is critical, both Professor Baumgartner and Dr. Grau gave evidence that every batch of mettwurst produced should be pH tested after 48 hours (T.5606-9, and 5660). However, such testing should be more frequent when the process is set up initially. Mr. Wintulich, who impressed me as a conscientious and intelligent man who has given much consideration to the question of quality control of his product, gave evidence that he carries out frequent pH testing only when procedures are changed or where a discernible difficulty with the product has been demonstrated. Otherwise, he considers random pH testing sufficient (T.3388). However, it seems to me that the difficulty with that approach is that unless the product is tested very frequently, by the time a difficulty has been demonstrated, a large quantity of product may have been released for consumption.

It is my view that the two expert witnesses ought to be accepted, and that all batches of fermented sausage should be pH tested, at least after 48 hours fermentation time, and more frequently where necessary. Recent improvements in the utility and convenience of pH meters make this a simple and speedy process, and in my view there is no reason for not doing it.

(f) Standard operating procedures

Garibaldi had no written specifications or standard operating procedures which dictated what should occur during its manufacturing process. A flow chart, said to have been prepared in 1994 (see Exhibit C.158e), gives no specifications as to temperature, humidity, and the stages at which various criteria should have been achieved. Control of the process was in the hands of Lou Marchi, but evidence of Mr. Basilico, foreman-in-charge of that area (see T.4439 and 4446-7), was inconsistent with the evidence of Lou Marchi (T.4958) as to Garibaldi's manufacturing system.

The criteria for determining whether fermentation/maturation had occurred appropriately was an entirely subjective one in the sense that Mr. Marchi said that he could tell merely by looking at the sausage, feeling it and occasionally cutting it to see if it had cured appropriately (T.4996).

(g) Water activity monitoring

The monitoring of water activity is a vital step in the mettwurst manufacturing process since micro-organisms require the presence of moisture to proliferate. As the product dries out during the maturation phase, the micro-organisms which have survived the fermentation process but which have been damaged thereby, will die as moisture leaves the product. If the product retains too much moisture, some of the micro-organisms will survive and begin to proliferate again. The test results obtained by Dr. Andrews in 1992 are indicative of this.

Professor Baumgartner, Dr. Grau and Dr. Andrews all suggested that it was necessary to monitor water activity during production. Although it is possible to monitor it precisely using a scientific device, a simpler but less accurate measure is to weigh the product at various stages in the process. Once proper standards have been set using exact measurements, any departure from the standard detected by weighing will give an indication that something may be wrong with the process (T.5663-4). Mr. Wintulich gave evidence that he weighs his product every day for that purpose (T.3354), and carries out more accurate water activity tests periodically (T.3389). This is the correct approach.

Dr. Andrews' water activity test results in 1992 were indicative that there was something seriously wrong with Garibaldi's process (Dr. Grau T.5675), and Professor Baumgartner agreed that the results indicated a lack of control over the process (T.5581, 5676).

Mr. Lou Marchi, the Managing Director of the company and the person in charge of production and most intimately connected with the process, said that he did not understand the significance of water activity or content as a safety issue, including its importance in relation to the growth of micro-organisms (T.5027). This is most surprising in view of Dr. Andrews' report (Exhibit C.99c).

(h) Pasteurisation

It was generally agreed by the experts that pasteurisation would be effective in eliminating harmful micro-organisms. However, the survey carried out by Ms. Anear established that only one out of 24 manufacturers carried out such a process in 1994 (T.2562-3). Presumably, this one manufacturer was Mr. Wintulich.

However, the experts also agreed that pasteurisation changes the nature and flavour profile of the product, and creates a different product from the one intended.

If pasteurisation was the only way in which public health could be assured, then I would recommend that it be made mandatory in relation to fermented products. However, the evidence convinces me that it is possible to ensure public safety while stopping short of requiring pasteurisation. I will deal with this topic later in these findings.

(i) The maturation process

Garibaldi had no Standard Operating Procedures in relation to the maturation of their product either. The flow chart I have already referred to does not stipulate a maturation time (see Exhibit C.158e). The practice of the company was to place the product in one of two air-conditioned maturing rooms, from which it was then transferred to a drying area. The mettwurst was moved on trolleys which contained racks of sausages suspended on string from wooden cross-pieces. The trolleys were placed in order of age and packing room staff could remove products from either the drying area or the drawing room (one of the air-conditioned maturing rooms) when required (T.4998).

The evidence as to how long the product took to mature or dry was contradictory. While Mr. Rose said that he was informed that mettwurst spent between two and four weeks in the maturation area (T.2083), Philip Marchi said that that period related to the time elapsed between the date the skins were filled and completion of maturation. He said that more often than not mettwurst was released after two weeks rather than four weeks (T.5525), whereas Lou Marchi said that mettwurst only took between seven and eight days after filling (T.4960), although he later contradicted himself (T.4995).

Despite Mr. Marchi's denials, I agree with counsel assisting me at the inquest, Mr. Bell, that there is compelling evidence that on occasions a product was released before it was fully matured.

Lou Marchi admitted as much during the conversation on 8 March 1991, to which I have already referred (Exhibit C.93a), in which he said that Casalingo salami took five to six weeks to mature (p.2), but that Casalingo salami could be released as early as two weeks, "based on customer demand" (p.3).

Although both Lou and Philip Marchi told me that they were the only people authorised to release mettwurst and salami for sale, in practice other workers allowed products to be released without obtaining their authority (see the evidence of Mr. Cavallaro (T.4647, 4657), Mr. Commisso (T.4713), Mr. Bacolo (T.4807, 4809, 4816)).

The packing room supervisor, Mr. DeBlasio, told me that sometimes mettwurst was sent out only two or three days after it had been made, and that people often preferred it "fresh" (T.4902).

The only conclusion I can draw from this evidence is that Garibaldi had a haphazard and subjective system which was not subject to any consistency or overall control. Decisions to release products for sale were based upon subjective impressions of its readiness, without any scientific criteria (particularly in relation to water activity) being considered.

Further, there is evidence that in the latter part of 1994, the company was under considerable pressure to increase its sale volume. The relevance of this evidence, was that this could have placed pressure upon employees, including the directors, to release a product before it was fully mature.

In late November and early December 1994, there were production delays resulting from machinery breakdowns. The "robot filler", the biggest and most efficient machine used for production of most mettwurst sizes of less than a kilogram, was not useable for five days from 24 November until 30 November 1994 (see the invoice from the electrical contractor, Exhibit C.261, and the evidence of Mr. Shepherdson, the maintenance man (T.4935-7). Additionally, the large bowl cutter broke down and was out of action for three days from 1 December 1994 (T.4932-4). Some of the employees asserted that these delays caused a panic in management (see the evidence of Siuzdak - T.3893-4 and 3909), and that the small bowl cutter which was used instead of the larger one could not maintain the production rate (T.3893). Support for Siuzdak's evidence came from Mr. Cursaro (T.3962) and Ms. Apostolides (T.3987).

Lou Marchi sought to minimise the effect of these breakdowns and said that they made no difference because other machinery was used instead (T.5008). He insisted that he had enough stock to meet orders, and denied that an unusually large amount of mettwurst was made in early December 1994 to make up the back-log (T.5102).

The batch production records, Exhibit C.67b, provide evidence that little mettwurst was made during the period when the robot filler was broken down, and that large amounts were made once it was fixed.

Many witnesses gave evidence that the mettwurst produced around this time, particularly the 575gm size, was softer and fresher than normal. Such evidence from Garibaldi employees came from Mr. Cavallaro, (T.4658), Ms. George (T.4674), Mr. Santucci (T.4692), Mr. Commisso (T.4713), and Mrs. Joyce (T.4732).

Mr. Matson, a mettwurst maker from the Barossa Valley who purchased some Garibaldi mettwurst in November 1994 for the purpose of comparing it with his own product, also remarked on how soft and fresh it was (T.4834). Retailers including Mr. Tassone (T.635) and Mr. Rolton (T.1066) gave evidence that the 575gm bonus packs were softer and fresher than usual, and Mr. Anthony Savvas from Con's Fine Foods in the Central Market said that the degree of maturation of Garibaldi mettwurst delivered to him was variable (T.1020).

From this it can be concluded, with some confidence, in my view, that mettwurst produced in late November and December 1994 was released earlier than usual, and had not undergone the usual (and sufficient) degree of maturation. This would have given rise to a far greater risk that pathogenic bacteria in the product survived and proliferated (see the evidence of Mr. Murray, T.3204).

(j) General hygiene issues

Although the factory was modern, having only been constructed in 1989, there was some criticism of the premises and in particular the standard of cleanliness in the work areas. In particular, Mr. John Gilbert (T.3830), and Mr. Juhas (T.4103), were particularly critical of the lack of cleanliness and hygiene practices at the factory. However, these allegations were denied by the management witnesses, and I have already referred to the fact that I was impressed with the evidence of Mr. Nowak, the production supervisor at the time. Without going into details, it would appear that Mr. Nowak had some difficulty in getting employees to comply with his hygiene requirements, and it would seem that he was not receiving sufficient support from management in that regard until he threatened to resign in October 1994. Following that, he received much more support from management (T.4173). After that time (and neither Mr. Gilbert nor Mr. Juhas were employed at Garibaldi by then), I consider that conditions probably improved.

Dr. Andrews, who spent a substantial amount of time at the factory, found it "acceptable" in terms of cleanliness and hygiene (T.3564), and Mr. John Gooch, formerly the Plant Manager at Geo. Chapmans Smallgoods, described the Garibaldi factory as "easily the best I've seen", and he explained that his comment applied to factories he had seen both here and in Europe (T.4583).

Further, I have already mentioned the report from Qantas Catering Service dated 16/6/94 (Exhibit C.156b) following an unannounced visit to the factory on 23 May 1994 (see p.63).

Taking all these matters into account, I conclude that, despite occasional lapses, which might be expected from any such facility, the standard of cleanliness was generally satisfactory.

(k) Reworking

The term "reworking" refers to products being re-used as ingredients in other products instead of being discarded. In this context, there are a number of variations of the practice:-

· off-cuts of products which had not left the factory and which were still fresh were sometimes recycled into cooked products such as "salami cotto" (pizza ham). Provided the product to be recycled is fresh, and the cooking process is adequate, there is nothing wrong with this practice;

 

· a product which has been returned from the market place, perhaps because of defective packaging, was also reworked into cooked products such as salami cotto. These products could have been beyond their use-by date, although Mr. Berginetti, Mr. DeBlasio or Mr. Tranfa inspected the product prior to its being re-used. Anything that smelled "off" or appeared rotten was said to have been thrown away. However, a number of witnesses said that the quality of this product which was reworked into salami cotto was not good, and was indeed "off".

 

For example, the witness Dean Anthony Shepherd, who was employed at Garibaldi for six months in 1987, alleged that Ross Marchi directed him to remove the clear packaging from about 50 kilograms of returned smallgoods. He said that these goods had passed the use-by date (T.3625), and that they had a green slime on them which "I thought was probably salmonella" (T.3626). After this, the smallgoods were placed in the same refrigerator as the one where fresh product was stored. He also saw several of the boners in the boning room doing the same thing on a couple of occasions (T.3627), and he saw the returned smallgoods being minced and mixed with fresh meat, placed in tubs and put in the refrigerator (T.3628).

Shepherd also alleged that an employee named Anthony (who remains unidentified) told him that "all the shit in the world" went into pizza ham (salami cotto) (T.3642).

Reworking of product which has left the factory into another cooked product is unlawful, since it is a breach of regulation 15 of the Food Hygiene Regulations 1990, made pursuant to the Food Act. It is a particularly undesirable practice if the product being reworked is of poor quality. The practice would be an even greater cause for concern if the product were being reworked into an uncooked fermented product such as salami and mettwurst. There was evidence from Mr. Carna (T.3760), Mr. Samson (T.3880) and Mr. Juhas (T.4117) that returned products were reworked into mettwurst. However, Juhas' evidence was hearsay, and when examined more closely on the topic, it would appear that Messrs. Carna and Samson were not prepared to go further than suggest that such products were reworked into salami cotto (see T.3763, 3768). Since salami cotto is a cooked product, I accept that the risk of contamination is much lower. This does not condone the practice of reworking returned product in any circumstances, however.

In all those circumstances, I find the evidence that any product was reworked into mettwurst is insufficient to form a conclusion, and that in any event there is no evidence that such a practice occurred during the relevant period to the extent that it may have had a causative effect on the outbreak in January 1995.

(l) Repacking

Another practice which is cause for some concern is known as "repacking", in which a product returned from the market place was repacked, and new "use-by" dates were applied. The evidence of Ms. Darrall (T.4481) indicates that this practice was adopted on occasions. Although there was evidence that fermented products generally were useable well beyond the use-by date initially applied to them, such practices represent a complacent attitude towards food hygiene, and should be discouraged. After all, who would know whether a product might have been returned and repacked on more than one occasion, and how could it be assured that such product might have been stored and cared for appropriately while it was out in the market place. In my view, no responsible food manufacturer should engage in such a practice. It is for the SAHC to consider whether it constitutes a breach of regulation 15 of the Food Hygiene Regulation referred to earlier.

8. THE EPIDEMIOLOGICAL INVESTIGATION

(a) What is an epidemic?

The Shorter Oxford Dictionary defines an "epidemic" as "a temporary but widespread outbreak of a particular disease". Dorlands Illustrated Medical Dictionary defines it as "occurring suddenly in numbers clearly in excess of normal expectancy; especially of infectious diseases ...".

In the procedure manual entitled "Food-Borne Infection and Intoxication Outbreaks" prepared by SAHC in 1992, "outbreak" is defined as:-

"An incident in which two or more persons experience a similar illness after ingestion of the same food, or after ingestion of water from the same sources and where epidemiological evidence implicates the food or water as the source of the illness".

(Exhibit C.88d, p.5).

This is to be contrasted with a single or "sporadic" case which is defined in the same document as:-

"one case, as far as can be ascertained, unrelated to other cases in respect to consumption of food or water, or contact with water".

 

A definition which relies upon the identification of a common source begs the question to some extent. Firstly, it may be that an outbreak is obvious, as it was here, prior to identification of the source of the illness. Secondly, the expression "two or more persons" is so vague as to be unhelpful. To illustrate, Mr. Bell asked Dr. Scott Cameron:-

"Q. How does that assist you ... say two people become ill a month apart. Is it because those cases occur a month apart. Are they both regarded as sporadic cases, or can they be considered to be a possible outbreak, because the food may have been available over the whole month's period.

A. They may well be considered as unrelated, unless there is something peculiar about the agent. With salmonellas it may be an unusual serotype which we simply don't see and so to have two of them would be unusual even if they are separated by three or four weeks, but if it was a common type of typhimurium, we would probably never realise that they were part of an outbreak."

(T.2767).

Taking the evidence of Drs. Kirke and Cameron in context, and consistent with Dorlands definition, it seems that the first step in ascertainment of whether an epidemic is occurring is to ascertain the number of cases of a particular illness which might be expected in a given period. For example, in this case after the cases of Sadler and Faulkner were reported to the SAHC on Monday 16 January 1995, Dr. Cameron consulted his epidemiological colleagues interstate to ascertain the expected incidence of HUS in Australia. Concluding that, together with the case of Vanderkop, three cases in the space of a month was more than what might normally be expected, the conclusion was reached that an epidemic may be occurring.

There is a nice question as to whether, if the SAHC had been notified of the case of Sadler on 10 January 1995 when HUS was diagnosed, that case, when combined with the case of Vanderkop, constituted an epidemic. Although Dr. Cameron did not say that it would have done, his evidence was that such a notification "would have been unusual enough for us .... to ask more questions" (T.2770).

(b) Responsibility for the investigation

The Public and Environmental Health Service is a division of the South Australian Health Commission. Its Executive Director is Dr. Kerry Kirke. One branch of that service is the Epidemiology Branch. Within that branch is the Communicable Diseases Control Unit ("CDCU"), and the manager of that unit is Dr. Scott Cameron. Dr. Cameron was in charge of the epidemiological investigation in relation to this case. Mrs. Caroline Walker was employed in the unit as a clinical nurse and her function was to carry out the investigation, particularly in relation to interviews with parents of the victims, in order to trace consumption of food, and in order to identify what may have been common factors among the victims.

(c) Chronology

A brief chronology of the epidemiological investigation is as follows (I emphasise that this is not an extensive list of everything done by SAHC during the investigation - it merely serves to illustrate the sequence of the main events):-

4 January 1995 . case of Michelle Vanderkop notified to CDCU by Dr. Goldwater from WCH.

. No action taken - treated as sporadic case;

 

16 January 1995 . notification of cases of Sadler and Faulkner to CDCU by Dr. Goldwater.

. Dr. Cameron instructed Mrs. Walker to make inquiries with other Australian health authorities.

. Query treated as an outbreak;

 

17 January 1995 . case of DePasquale notified to CDCU by Dr. Goldwater.

. Meeting at SAHC at 3.00p.m. At 3.56p.m. Dr. Goldwater faxed copies of interviews with parents of victims to date.

. Mrs. Walker drafted first questionnaire (Exhibit C.77b).

. Dr. Kirke informed by Dr. Cameron of the outbreak;

 

18 January 1995 . notification of Branson and Cohen White's cases to CDCU.

. Minister informed - written briefing provided.

. Public health notice issued (Exhibit C.88a, SC2).

. Mrs. Walker interviewed Ms. Vanderkop;

 

19 January 1995 . cases of Nikki White and David Buck reported to CDCU.

. SAHC advised that E.Coli identified as cause of HUS.

. Mrs. Walker interviewed Sadler and Faulkner families at home with Ms. Manatakis, who took food samples.

. Mrs. Walker interviewed parents of DePasquale at hospital.

. Notification of Buck case from Canberra;

 

20 January 1995 . further Ministerial briefing memorandum from Dr. Kirke which identifies E.Coli organism contaminating raw or inadequately cooked food - "possibly processed meat products" as the likely cause (Exhibit C.88a,, SC8).

. Media release by SAHC, "Epidemic of severe childhood illness".

. Interviews with Branson family, White family and Buck family (per telephone).

(by the afternoon of Friday 20 January 1995 Mrs. Walker had interviewed all of the parents of the eight cases reported by then. In six of the eight cases mettwurst had been eaten, in five of the eight cases fritz had been eaten. Of the six who had eaten mettwurst, three cases were identified as Garibaldi mettwurst).

. Discussion between Mrs. Walker and Dr. Cameron and Mary Beers re results of interviews. Mrs. Walker remarks on spicy diet of children. Fritz postulated as the common link. No mathematical assessment of information from interviews. Dr. Cameron did not read the results (T.2250-1).

. Timothy Faulkner faecal sample screened positive on PCR test for SLTEC;

 

21 January 1995 . no further investigations performed.

. Nikki Robinson and Kelly Owen consumed mettwurst;

 

22 January 1995 . Dr. Cameron advised by nurse from WCH that two parents (Branson and St.Clair) had identified that their children had eaten the same brand of mettwurst (T.2785).

. Dr. Cameron later spoke to Mr. St.Clair and identified Garibaldi garlic mettwurst.

. Jack Culshaw, Lauren Adamcewicz and Michael Bailey consumed mettwurst;

 

23 January 1995 . (about noon) Dr. Paton advised Dr. Cameron that mettwurst taken from Faulkner household positive on PCR test for SLTEC. Identified as Garibaldi garlic mettwurst.

. Garibaldi (Philip Marchi) advised by Nick Rose (SAHC).

. 3.00p.m. media conference - Acting Minister of Health - Garibaldi garlic mettwurst identified - use-by date 12 March.

. Steven Baulderstone and Lauren Adamcewicz ate mettwurst;

 

24 January 1995 . Scott Granton and Samuel Fuentes ate mettwurst;

 

27 January 1995 . Aaron Ross ate mettwurst.

 

I do not mean the above list to imply that Dr. Cameron and his staff were otherwise idle during that period. I accept that they were not. As Dr. Cameron said (at T.2898):-

"Q. What role did you play, yourself, in that week of 16 January, in terms of the investigation. What was your function?

A. As I tried to indicate, I was trying to, one, keep the unit running, and, two, try and - to allocate resources to the task and to maintain liaison with a number of bodies who were involved, or could give us information, and they included the IMVS, the WCH, all of the hospitals, the CDC in Atlanta, the network of all the public health authorities around Australia, the media. It was a difficult task, but much of the technical data I had to leave to the professionals who had been tasked with it".

 

(d) Connection with Garibaldi

It is apparent from the above brief chronology that the positive connection between Garibaldi garlic mettwurst and the HUS illness was made at about midday on Monday 23 January 1995. This connection was on the basis of the microbiological investigation, with which I will deal shortly. The epidemiological investigation had not produced a result by that stage. Indeed, the conversation between the parents of Emma St.Clair and James Branson on Sunday 22 January at the WCH was the closest that the investigation came to an epidemiological connection prior to Monday. In that sense, it can be asserted that the epidemiological investigation was unsuccessful.

Dr. Cameron asserted in evidence that he made the decision to recommend a public announcement on Monday the 23rd on the basis of the epidemiological evidence, "bolstered" by the microbiological tests" (T.2789). I reject this contention. It seems to me that it was not until the parents identified Garibaldi garlic mettwurst on Sunday the 22nd, and Dr. Paton returned the microbiological test results between 11.00a.m. and noon on the 23rd, that the decision was taken. No further assessment of the epidemiological evidence collected by Mrs. Walker the previous week had occurred since Friday 20 January.

Of course, it is likely that once the parents' contentions, and Dr. Paton's test results became known, Mrs. Walker's results attained a clarity on the Monday which escaped them on the previous Friday afternoon.

Counsel for the Robinson family, Mr. Soulio, criticised those involved in the epidemiological investigation in relation to this outcome. In effect, he submitted that had the connection been made on Friday 20 January, and the Ministerial announcement been made that afternoon, Nikki Robinson might not have consumed the mettwurst she ate on Saturday 21 January. It is therefore necessary to evaluate the investigation in order to assess Mr. Soulio's contention.

(e) Effectiveness of investigation

(i) Knowledge of the disease

It would appear that Dr. Cameron and his staff had access to textbooks and other source material at an early stage of the investigation. Dr. Cameron gave evidence on 16 January 1995, that when he first became concerned that an outbreak may be occurring, he consulted Beninson, a standard text on food-borne diseases (T.2824).

Dr. Cameron was aware at an early stage that the outbreak was likely to be food or drink related (T.2818).

The staff at CDCU were not aware of the most recent outbreak of a similar disease, but they cannot be criticised for that. This outbreak had occurred in California in November and December 1994, and involved infection by a strain of E.Coli known as 0157. The source of the infection had been established as salami. This information did not come to hand until 27 January 1995, by means of the Morbidity and Mortality Weekly Report. This was, of course, too late to be of any use in this investigation.

It is surprising that such information takes such a long time to become available to practitioners in the field. With modern means of communication, and with the ability to rapidly search computer data bases, such information should be available much more quickly. With modern communication technology, it would be a simple matter for such a publication to simply carry an "alert" to practitioners of such outbreaks, even if it is not possible at an early stage to provide a detailed report into the circumstances. Such an alert might provide communication information so that practitioners who might be faced with a similar outbreak could contact those involved for helpful information. If such information became available on the "Internet", the information could be passed almost instantaneously.

(ii) Knowledge of the Product

Dr. Cameron only had a vague idea of how salami and mettwurst were produced. He was aware that salami was a fermented product which was not usually pasteurised but that mettwurst had "some heating in it and salamis tended not to" (T.2740). Mrs. Walker also had no real idea about how either product was produced (T.2229).

While such lack of knowledge is not surprising in practitioners in a Communicable Diseases Control Unit, I am somewhat surprised that the information, which was readily available to them from members of the Food Standards Section of the Environmental Health Branch of the Health Commission (who were assisting with the investigation), was not utilised. Both Mr. Rose and Mr. Hobson were aware that mettwurst was a generally uncooked fermented product (T.1932, T.2412). In my view this information was vital, in order that the epidemiologists could assess the risk of particular products being implicated in the epidemic.

As the evidence before me in relation to Garibaldi's manufacturing process clearly demonstrated, the risk of transmission of the toxic bacteria is far greater in uncooked fermented product than it is in cooked products such as fritz, which was regarded as at least an equal contender with mettwurst when the matter was discussed by Dr. Cameron and Mrs. Walker on the previous Friday.

(iii) Methodology

As I have already mentioned, a procedure manual or protocol had been developed in 1992 for the investigation of food-borne infections (Exhibit C.88d). However, the evidence was that Mrs. Walker did not have a copy of that document (T.2310).

Exhibit C.88d provides a detailed procedure and in particular an elaborate and complex flow chart for the purpose of planning such an investigation. Even if the staff in the CDCU did not have a copy of the manual, it seems to me, on the evidence, that the procedure outlined therein was substantially complied with. The initial process, as the chronology I have already outlined demonstrates, was that there was a review of data to determine whether or not an outbreak was occurring, and then a collection of data in order that epidemiological associations could be established. The most obvious steps in that process in this case were the interviews of parents to obtain the history of food consumption, and the obtaining of food samples. This methodology proceeded in an orderly fashion, although Mr. Soulio was critical of the time taken. I will deal with this issue under another heading. On review of the evidence, however, I am unable to find ground for criticism of the general methodology of the investigation.

(iv) Development of Questionnaire

As I have already outlined, Mrs. Walker was deputed by Dr. Cameron on Monday 16 January 1995 to design a questionnaire for the purpose of her interviews of the parents to obtain the history of food consumption. The first such questionnaire was prepared on Tuesday 17 January 1995 by Mrs. Walker and is Exhibit C.77b. Mr. Soulio criticised this delay on the basis that the questionnaire which she eventually produced did not differ in any material way from one which was already available.

While Mr. Soulio's criticisms are factually correct, it does not necessarily follow that simply because, after a proper degree of research, the questionnaire eventually produced was similar to one already available that the time spent on research was necessarily wasted. Although I am sure she used her best efforts, it seems to me that, since Mrs. Walker had the assistance of Ms. Beers and Ms. Feldhein (T.2305), the realisation that the questionnaire required for the HUS outbreak need not have been different to the one already available, might have been realised more quickly.

Another criticism in relation to the questionnaires is that the incubation period specified on Exhibit C.77b is one to three days.

Dr. Cameron had already remarked in an article in 1986 in relation to a salmonella investigation, that "limiting the history taking to three days prior to illness made it likely that the source of many infections would not be mentioned - we hope that others may learn from our experience" (see Exhibit C.88b).

Mrs. Walker argued that the specification of the incubation period did not limit her in her questioning, since she said that she attempted to ascertain what was generally eaten by the child, and that the information thereby elicited was not limited to the three day period (T.2236). This may well be so, and there is no evidence that the questioning became ineffective as a result of the specification of an incubation period which was too narrow. However, the practice is clearly undesirable, for the reasons expressed by Dr. Cameron.

(v) Parent interviews

Mr. Connell, in his submissions, criticised Mrs. Walker on the basis that a delay of three days took place before the parent interviews commenced (submissions, p.24).

In the file note prepared by Mrs. Walker she notes that the first parent interviews took place on Thursday 19 January 1995 (see Exhibit C.77a, p.3). However, in evidence, Mrs. Walker said that the first parent interview took place on Wednesday 18 January with Ms. Vanderkop (T.2233). Mrs. Walker's interview notes, prepared at the time, are also dated 18 January 1995 and so it seems likely that the earlier date is the correct one, which means that a delay of two days, not three, occurred (see Exhibit C.77g).

However, such a delay still seems substantial in view of the urgency of the situation. The interviews were arranged with parents at their homes so that both Mrs. Walker and Ms. Manatakis could attend and, while Mrs. Walker conducted the interviews, Ms. Manatakis collected any samples which were necessary.

In his submissions, Mr. Shephard, counsel for SAHC, suggested that there was "a necessity to accommodate concerned and often distraught parents who did not wish to leave the hospital for officers to obtain food samples (see the evidence of Ms. Zabeta Manatakis at p.2536)". I do not accept that it was necessary for these interviews to have occurred at the parents' homes. In my view, the parents would have been anxious to co-operate with the SAHC officers, who were attempting to track down the source of the epidemic, and would have been happy to discuss the issue with Mrs. Walker if she had attended at the WCH for the purpose of the interview. A further appointment could have been arranged at the home if there were samples to be collected, and that was probably a less urgent requirement in any event.

In my view, had Mrs. Walker attended at the WCH, say on Tuesday 17 January 1995, a substantial number of those interviews could have been conducted that day. To that extent, I consider that Mr. Connell's criticism of the performance of the SAHC is justified, although I accept that the delay was well-intentioned, with the welfare of the parents being the paramount consideration of the SAHC officials.

(vi) Analysis of data

As I have already observed, Mrs. Walker and Dr. Cameron discussed the results of Mrs. Walker's investigations on the afternoon of Friday 20 January 1995. However, the discussions were inconclusive and really consisted of Mrs. Walker providing Dr. Cameron with impressionistic overviews of her week's activities, rather than any mathematical analysis of the information she had produced.

If such an analysis had been undertaken, it would have disclosed that of the eight children then involved, six of them had consumed mettwurst and three of those children had consumed Garibaldi mettwurst. In view of the fact that only five of the children had consumed fritz, it is difficult to understand why Mrs. Walker and Dr. Cameron thought that that was an equally likely alternative. Had Dr. Cameron and/or Mrs. Walker known or found out about the process by which these products were produced, I am sure they would have realised at an earlier stage that mettwurst was far more likely to have been the cause of the problem.

Dr. Cameron told me that there is a computer programme available by which such an analysis can take place. The programme was designed at the Centre for Disease Control in Atlanta, Georgia.

That computer programme was not utilised on or before 20 January 1995, I suspect because too few interviews had taken place for there to have been sufficient data to warrant it. It seems obvious that with only a small number of interviews having taken place, the mathematics could have been done manually and the computer was not required.

Unfortunately, in this case, the mathematics were not done manually either.

Mrs. Walker conceded that had she ascertained that six of the eight victims had eaten mettwurst or had had contact with mettwurst on Friday 20 January 1995, her approach may have been different (T.2321).

There is a contradiction between the evidence of Dr. Cameron and Mrs. Walker as to whose task it was to analyse the data. Dr. Cameron asserted that he relied upon Mrs. Walker for that purpose (T.2833-4), whereas Mrs. Walker's evidence was that her task was merely to collect the evidence and that the analysis was up to Dr. Cameron (T.2328). This lack of clarity in the responsibilities of the respective officers is a serious deficiency in the operation of the CDCU, and should have been rectified prior to the outbreak of this epidemic. Mrs. Walker does not have academic training in either epidemiology or statistics, whereas Dr. Cameron has training in both.

In my view, the primary responsibility for the analysis of this data was Dr. Cameron's, and could not be avoided simply by delegating it to Mrs. Walker on the basis that he had confidence that she would perform the task. It was his responsibility to ensure that she had the knowledge, training and experience to have carried out the task properly, and that she clearly understood that it was her role to do so, before delegating the task to her. If she did not, then he should not have delegated the task to her.

In those circumstances, it would seem to be clear that these organisational deficiencies resulted in a failure, as at Friday 20 January 1995, to appreciate the significance of the data Mrs. Walker had collected to that stage. In view of the small numbers involved, it is surprising that the significance of the fact that six out of eight children had eaten mettwurst was not realised earlier. Indeed, Dr. Kirke, the Director of the Public and Environmental Health Branch, said:-

"If there was a common factor of mettwurst in six of eight cases then, if (neither of) those two professional people, whose job it is to do this work, hadn't recognised it, I would be astonished".

(T.3038).

(f) Notifiable Diseases

Section 30 of the Public Environmental Health Act, 1987 provides:-

"Where a medical practitioner becomes aware that a person is suffering from a notifiable disease or has died from a notifiable disease, the medical practitioner -

(a) shall as soon as practicable, and in any event within five days of becoming so aware, report the existence of the disease to the Commission".

 

A "notifiable disease" is defined in the Schedule to the Act as including "food poisoning".

In the same way as the definition of "epidemic" does, this requirement begs the question of what the doctor's responsibilities are in a situation where, in a condition such as HUS, the disease is not notifiable until such time as the connection with the ingestion of food has been established. In the context of this outbreak, this was not possible until Monday 23 January 1995, when the first of the microbiological results became available.

Whether or not he was legally obliged to do so, Dr. Goldwater, the Clinical Microbiologist at the WCH, said in evidence that it was his practice, and he had set in place a procedure in his laboratory to give effect to it, that all such cases of HUS were reported to the Health Commission in any event (T.2608).

Notwithstanding this practice, Michelle Vanderkop's case, HUS having been diagnosed on 27 December 1994, was not notified to the Health Commission until 4 January 1995. Joshua Sadler was diagnosed on 10 January, but his case was not notified until 16 January. Timothy Faulkner was diagnosed on 14 January, and notification took place on 16 January at the same time as Joshua Sadler. Dr. Goldwater said in evidence that he was surprised at the delays in relation to the first two cases (T.2626), and that he was unable to explain them, particularly in relation to Sadler. The non-report of Vanderkop may have been explicable on the basis that Dr. Goldwater was on leave on 27 December, and did not return until 4 January (T.2697). In any event, the Notifiable Diseases Section of the Health Commission was closed over Christmas until 4 January (T.2697).

I have already mentioned Dr. Cameron's evidence that, had he been informed of Joshua Sadler's case earlier, he might at least have been alerted to the possibility of an emerging epidemic, and that it would have been "unusual enough to ask more questions" (T.2770).

Both Mr. Shephard, counsel for the Health Commission, and Mr. Harris, counsel for the Womens and Children Hospital, argued that no criticism was due to Dr. Goldwater and his staff for the non-report of Joshua Sadler's case since there was no legal requirement to make the report in any event. In my view, this is a rather disingenuous submission, in view of the long-standing practice adopted by Dr. Goldwater's staff of reporting these cases. No matter what the reason was for the delays, they were unsatisfactory, and Dr. Goldwater was clearly disturbed by them.

The informal arrangement between Dr. Goldwater and the Health Commission was effective (provided it was complied with) as far as it went. However, it seems to have proceeded on the assumption that all HUS cases would pass through the WCH in the initial stages, and that the SAHC would thereby get the earliest information. This inquest has demonstrated that this will not always be the case. Several of these children spent several days in other hospitals (e.g. Lyell McEwin Hospital, Flinders Medical Centre), prior to their admission to the WCH. Although Dr. Jureidini told me that they remained in contact with these other hospitals, no notification to the Health Commission took place until the child arrived at the WCH. The arrangement is therefore defective to this extent and in my view justifies legislative attention.

In my opinion there is a need for a review of the provisions of Section 30 of the Public and Environmental Health Act. There are several areas where the Act needs to be reconsidered:-

· The use of the expression "is suffering from a notifiable disease" indicates that a definite diagnosis needs to have been made by the practitioner before there is a requirement to notify. Consideration should be given to making notification mandatory if the practitioner believes that the patient "may be suffering" from such an illness so that reports are made on a much earlier basis than present.

 

· The limit of five days needs to be reviewed, since although the section also refers to "as soon as practicable", medical practitioners will naturally regard five days as the limit, and this is too long in infectious disease epidemics.

 

· Consideration should be given to making HUS a notifiable disease in its own right. I accept the arguments of counsel that making haemorrhagic colitis notifiable will be counter-productive, since it would result in a multitude of reports which would not be epidemiologically useful. However, as soon as HUS is suspected, in my view it should be notifiable so that the epidemiological investigation can commence.

 

· Consideration should also be given to whether the adult syndrome of TTP (thrombotic thrombocytopaenic purpura) should be a notifiable disease for the same reasons as apply to HUS. In my view, it should be.

 

(g) The McAnaulty Review

Dr. J.M. McAnaulty, the Director of the Southern Sydney Public Health Unit, was commissioned by the SAHC to carry out an independent review of their response to this outbreak. His report is Exhibit C.89.

At p.5, Dr. McAnaulty concluded:-

"The investigation into the HUS outbreak by SAHC between January 4 1995 when the first case was notified, until January 23 1995 when the public health action was taken, was thorough and the public health action taken was appropriate. The investigators completed the relevant steps of the outbreak investigation and gathered evidence supporting the hypothesis that the HUS outbreak was caused by consumption of Garibaldi mettwurst".

 

However, Dr. McAnaulty conceded that some form of analysis should have occurred on the afternoon of Friday 20 January 1995. He said:-

"Q. Do you agree with me that if a proper review had been done on Friday, the 20th, it should have been ascertained that six out of the eight children had eaten mettwurst?

A. Yes".

 

To that extent, I do not agree that the investigation was thorough.

In making that criticism, I remain mindful of the dangers of hindsight. Dr. McAnaulty said, at T.2941:-

"Q. I want to you to assume that on the Friday the 20th, whatever review was done by Dr. Cameron and Mrs. Walker, it did not reveal to them, either one or the other, or together, the fact that there was evidence implicating mettwurst in relation to six of the children. I want you to assume that fact. On the basis of that assumption, would you still say that the investigation into the outbreak was well conducted?

A. Yes.

Q. Why.

A. Because I believe that in any investigation there are a number of factors and a lot of information coming in at once and that it does require time to collate that, physically and mentally put together a picture in your mind of exactly what is happening. It is fairly easy, in retrospect, to do that, because we know now what the cause was, but at the time there was, I would guess from my experience in doing other outbreaks, a lot of information coming in at any one time".

(T.2941).

While I accept the strength of that argument, I consider that Dr. McAnaulty is being unduly generous to the SAHC in describing the investigation as well-conducted. The fact is that a proper review of Mrs. Walker's results did not take place on Friday 20 January 1995, and it should have done. I think that the Health Commission should be criticised for that.

(h) Conclusion

It is true that on Monday 23 January 1995 the SAHC acted with commendable zeal in recommending to the Minister that he announce the connection between Garibaldi garlic mettwurst and the HUS illness on that day, in view of the microbiological evidence available at that time. Even one of the prime movers of the microbiological investigation, Dr. James Paton, described it as a "brave step" (T.1676). Mr. Soulio, on behalf of the family of Nikki Robinson, submitted that had the epidemiological investigation proceeded with greater haste during the previous week (had, for example, the questionnaire been developed within an hour or two, and the interviews with parents occurred on the 16 or 17 January instead of the 18th, 19th and 20th), the conclusion that Garibaldi garlic mettwurst was involved could have been reached at a much earlier stage and not later than Friday 20 January.

He argued that, had the Health Commission acted with similar zeal on that day, the chance exists that Kelly Owen, Jack Culshaw, Nikki Robinson, Lauren Adamcewicz, Aaron Ross, Michael Bailey, Scott Granton, and Samuel Fuentes, or at least some of them, might not have eaten Garibaldi garlic mettwurst and become ill. I think that submission must be accepted.

9. THE MICROBIOLOGICAL INVESTIGATION

Dr. James Paton is a molecular microbiologist and is the Chief Hospital Scientist and Head of the Molecular Microbiology Unit at the Womens and Childrens Hospital. He has a Ph.D. in microbiology and 15 years of post-doctoral experience in the area. The laboratory he supervises at the WCH is principally a research facility and does not usually become involved in general clinical work.

Coincidentally, Dr. Paton's laboratory had been involved in a particular research project involving "shiga-like toxin-producing escherichia coli" (SLTEC), a recently recognised sub-group of the species of bacteria known as E.Coli, of which there are thousands of different strains. Dr. Paton told me that the majority of these strains do not cause illness in humans, and are found in the gut of most mammals. However, SLTECs are frequently found in the intestines of livestock, and can be the source with diseases such as HUS in humans.

By far the most common form of human infection is with the strain belonging to the O-antigen serotype 0157. This particular strain is easily detected and has been implicated in many outbreaks in the United States and Europe over the years. However, it is less common in Australia.

(a) Techniques adopted

Dr. Paton said that because of the bewildering variety of organisms which might be responsible for HUS (including some organisms which are not E.Coli), and also because the numbers of SLTECs in faeces drops markedly after a short time during the diarrhoeal phase of the illness, conventional detection techniques have proved inadequate. Accordingly, a polymerase chain reaction assay (PCR) was developed which is specific to shiga-like toxin-producing organisms. This assay is extremely sensitive. It is capable of detecting one SLTEC bacterium among 100 million other coliform bacteria (T.1583). This technique had been applied during 1994 to the detection of SLTECs in sporadic HUS cases seen during that year.

The procedure is as follows:-

· a faecal sample or faecal swab is obtained from the patient;

 

· this is then introduced into a broth and then on to Agar plates;

 

· the plates are incubated overnight, during which time bacteria multiply massively;

 

· crude DNA is extracted from the bacteria present in the broth culture;

 

· this is then assayed using the PCR technique referred to above. This technique recognises particular genes which encode both major types of SLTEC (SLTEC I and SLTEC II) and all known variants thereof;

 

· if a particular DNA extract is identified as containing the SLTEC gene it is then amplified using the PCR technique;

 

· the product of that amplification is then detected using electro-phoresis.

 

This process therefore effectively operates as a screening test which produces either a positive or negative result for the presence of SLTEC-producing organisms. The process that I have just described usually takes two days, according to Dr. Paton (T.1585), although it can be reduced to one day if the need arises.

If the PCR test is positive for the presence of SLTEC genes, a further test known as "hybridisation" is conducted in order to identify whether the gene is SLTEC I or SLTEC II, or both. This test requires a further 24 hours to complete.

Once this testing has been carried out, and a faecal sample has produced a positive result for the presence of shiga-like toxins, Dr. Paton said that it was reasonable to conclude that this was likely to be causing the HUS illness in the patient (T.1598).

The next step in the analysis is to carry out what Dr. Paton described as isolation of the SLTEC gene from PCR-positive cultures. This involves conventional microbiological techniques including picking off and testing colonies of bacteria and then using further hybridisation techniques using an SLTEC-specific DNA probe. The probes which identify the particular SLTEC organism were developed by Dr. Paton, in consultation with Professor Manning of the University of Adelaide, during the epidemic (T.1596), which gives an indication of the extent to which this was ground-breaking research, and how fortuitous it was that the epidemic occurred in South Australia, where the scientific expertise was coincidentally available, rather than elsewhere in Australia (see the evidence of Dr. Goldwater at T.2677). In some cases, up to 1,000 colonies have to be picked off and tested in order to isolate the gene. This can take weeks (T.1601).

Once the gene has been isolated, a further analysis, known as serotyping, is carried out to determine the serotype of the gene - i.e. whether the particular strain of the organism is for example E.Coli 0157, 0111 or whatever. This is the quickest part of the analysis, and can take only a few minutes. For the most part, this last phase of the analysis was carried out at the Institute of Medical & Veterinary Science (IMVS) in Adelaide (T.1600).

Each serotype of E. Coli, such as O111, can be further divided into sub-categories by further genetic analysis. Dr. Paton said that although this is not necessary in order to identify the source of the illness, it provided final confirmatory evidence to satisfy the scientists that mettwurst and salami were the source of the epidemic (T.1617).

(b) The initial tests

As I have already outlined, Michelle Vanderkop was admitted to the WCH on 26 December 1994. A PCR test of her faecal specimen yield was positive, and hybridisation established the presence of SLTEC II-producing genes. This was different to the results from all of the subsequent tests, in the sense that all of those specimens demonstrated that the organism was capable of producing both SLTEC-I and SLTEC-II genes (T.1592-3).

Joshua Sadler was admitted to the WCH (from Flinders Medical Centre) on 10 January 1995. On that day a specimen was received, and by 12 January the PCR screening test was positive. On Friday 13 January the presence of both SLTEC I and SLTEC II genes was established.

Dr. Paton said that the difference between Vanderkop and Sadler's results suggested that the first two cases were caused by different organisms and that it was unlikely that a common source of infection was involved. He further commented that:-

"The occurrence of two apparently unrelated (presumably sporadic) HUS cases within two weeks of each other was not unusual, as there was a similar cluster of cases admitted to WCH during early 1994."

(statement Exhibit C.63, p.4).

Timothy Faulkner was admitted to WCH on 14 January 1995, and Nicholas DePasquale on 16 January. Faecal samples from these two boys were received by Dr. Paton on 17 January and a positive PCR result for the presence of SLTEC-producing genes was obtained on Thursday 19 January. On Friday 20 January, hybridisation established that genes capable of producing both SLTEC I and SLTEC II were present.

On Wednesday 18 January 1995 James Branson, Nikki White and Cohen White were admitted to WCH. Samples were obtained that same day, and PCR tests in relation to all three children were positive for the presence of SLTEC-producing organisms by Friday 20 January.

By Thursday 19 January, Dr. Paton concluded that the three PCR-positive tests, clustered as they were so close together, were "unprecedented in South Australia" and he concluded that there was an epidemic taking place. He concluded that, since it was likely that there would be further cases arriving at the WCH, it was necessary to arrange for another laboratory to carry out similar testing on food samples collected. Accordingly, he arranged with the molecular microbiology section at the IMVS to carry out this analysis, and provided them with the necessary reagents for that purpose on Friday 20 January 1995.

Over the weekend of 21 and 22 January 1995, the food samples collected by Ms. Manatakis during the previous two days were analysed by the staff at the IMVS laboratory, principally Mr. Ratcliff and Ms. Doyle. The process was completed on Sunday morning the 22nd, and the results, including two presumptive positive results, were telephoned to the supervising technical officer, Mr. Peter Cameron, at around midday on Sunday 22nd (see Mr. Ratcliff's statement, C.92, p.2).

Dr. Scott Cameron telephoned the laboratory later that afternoon to confirm those results and he too was advised of the information obtained by Mr. Ratcliff.

(c) The connection with Garibaldi

On Monday 23 January 1995, Dr. Paton attended at the IMVS laboratory and viewed the results and confirmed the positive findings. These involved a PCR-positive result on two samples of food taken from the Faulkner household, one from a raw lamb shank, and the other from Garibaldi garlic mettwurst with a use-by date of 12 March 1995.

Dr. Paton concluded that, since the lamb shank was likely to have been cooked before consumption, the most likely source of the organism capable of producing an SLTEC toxin was the mettwurst. Notwithstanding the fact that the PCR result had not yet been confirmed by hybridisation, he concluded that the PCR-positive result for the presence of SLTEC-producing genes was sufficient to conclude that the mettwurst was unsafe for human consumption, whether or not it was the actual cause of the epidemic then being considered. He telephoned Dr. Cameron at about noon on Monday 23 January 1995 with that information (T.1629).

It was on the basis of this information that the decision was made to advise the Minister to conduct the press conference.

(d) Further testing

Following this development, both faecal samples from new admittees to the WCH, and food samples collected by the SAHC, were analysed using the processes outlined above, by both Dr. Paton's laboratory and the IMVS.

Twenty out of the 23 children disclosed a positive PCR result, and hybridisation established the presence of genes capable of producing both SLTEC-I and SLTEC-II.

Additionally, a variety of other SLTEC strains (including 0157, 026, 091, and 023) were isolated from faecal cultures from the patients who had eaten Garibaldi mettwurst. A number of these patients had diarrhoea but did not develop HUS. The fact that multiple SLTEC strains were found to be present is not surprising, according to Dr. Paton, as this may reflect the fact that the mettwurst might contain meat from more than one animal carcass, or indeed from more than one species of animal, each of which could be contaminated with different SLTEC strains. Alternatively a single carcass may have contained multiple SLTEC strains (see Exhibit C.63, p.6).

Significantly, the testing carried out established that in three cases (James Branson, Nikki White and Jack Culshaw), E.Coli.0111 producing both SLTEC I and SLTEC II genes were shown to match genetically the isolates from the mettwurst sampled in relation to those cases.

In many of the other cases, E.Coli 0111 producing SLTEC I and II was isolated from the faecal specimens from the patients, and in six of those cases the organism was also isolated from food samples taken from the household (Exhibit C.91b). Some of the cases which were negative for the presence of E.Coli.0111 (for example, Travis Posthuma, was negative because the faecal specimen was not obtained until after the diarrhoeal stage of the illness had passed (T.1637) ).

(e) Conclusion

When this evidence is combined with the fact that no further similar cases have arisen since Garibaldi products have been removed from the market place, it is safe to conclude that Garibaldi mettwurst and salami was the cause of the outbreak, and that the announcement made by the Acting Minister of Health on Monday 23 January 1995 (notwithstanding the fact that the tests were unconfirmed) was vindicated by subsequent scientific testing and analysis.

10. THE RECALL PROCESS

(a) The Ministerial Announcement

The first step in the recall process took place on Monday 23 January 1995 when the Acting Minister of Health, Mr. Lucas, conducted a press conference at about 3.00p.m. He released a Ministerial statement (Exhibit C.88a, SC11). Included in that statement, the Minister said:-

· "The Health Commission has established eight of the nine victims definitely ate mettwurst or had contact with mettwurst, and five of the victims definitely ate Garibaldi garlic mettwurst, so there is a very strong epidemiological link with this particular product".

 

· "However, irrespective of that link, the testing of the sample showed the presence of the toxin, and on those grounds alone, the Health Commission had a responsibility and legal obligation to act in the interests of public health by informing the public that this particular batch of mettwurst is unfit for human consumption".

 

(As I have already mentioned, Dr. Paton confirmed the validity of this statement (T.1629) ).

 

· most importantly, the Minister identified Garibaldi garlic mettwurst with a use-by date of March 12 1995 as being the sample which had shown the presence of the toxin.

 

Later that afternoon, Colin Clark, from the Food Standards Section of the Public and Environmental Health Branch of the SAHC, attended at the premises of Garibaldi at Old Port Road, Royal Park, and ascertained from Philip Marchi, a director of the company, that there was no further stock bearing that use-by date on the premises. At that time, Mr. Marchi took Mr. Clark to the various areas of the factory where such stock might have been kept so that he could satisfy himself of that fact.

It is to be noted that the mechanism of a Ministerial statement was adopted as a means of giving the announcement and the warning contained therein maximum publicity and exposure. The Ministerial announcement in fact received wide reportage in both the press and electronic media.

The fact that the particular batch of mettwurst carrying a use-by date of 12 March 1995 was mentioned in the announcement has been the subject of criticism from various counsel who appeared at the inquest. Dr. Cameron gave evidence that he felt constrained by the provisions of the Food Act to confine the announcement to the particular batch where there was evidence of contamination (T.2795). The difficulty involved with the course taken by the SAHC is that the evidence disclosed that the date of manufacture of a particular piece of mettwurst could not be established by reference to the use-by date. I will deal with this evidence in greater detail later. For the moment, it is pertinent merely to point out that, during these initial stages, nobody from the SAHC set out to establish that the reference to a particular use-by date was an effective method of identifying a contaminated batch.

The other problem was that the SAHC had no information as to whether or not any other products produced by the company (for example, salami) may have been equally contaminated. Knowledge of the way these other products were made, and of Garibaldi's methods, would have told them that this was indeed likely.

As a result of the fact that the announcement was confined to Garibaldi garlic mettwurst with a particular use-by date, a number of people consumed contaminated products after 23 January 1995, on the basis of a decision that the particular product being eaten was not covered by the Minister's warning.

For example, Scott Granton's mother gave evidence that she heard the public announcement on 23 January, but when she examined the mettwurst in her possession the use-by date specified was 5 April 1995 (T.360-370). Mrs. Leske, who supplied the mettwurst to Aaron Ross, purchased Garibaldi mettwurst on 27 January 1995 and specifically checked the recall date and ensured that it was different to 12 March 1995 (T.459, 462). Steven Baulderstone ate mettwurst both before and after the announcement after his mother checked the use-by date and found it to be 5 April 1995.

Another dimension to this issue is that three children had eaten Garibaldi mettwurst prior to the announcement on 23 January, namely Travis Posthuma, Lauren Adamcewicz and Steven Baulderstone, but when their mothers heard the announcement they checked the product eaten by their children and ascertained that it was different. Mrs. Posthuma had bought salami, not mettwurst, and thought she was safe (T.262), and Mrs. Adamcewicz checked the use-by date and it was 5 April and so she did not become concerned either (T.302). Although it is not possible to say, this false reassurance may have engendered less urgency when the children first became ill.

(b) The Voluntary Recall

At about 3.00p.m. on Monday 23 January, Philip Marchi from Garibaldi advised Nick Rose of the SAHC that the company was organising an immediate recall of the mettwurst referred to in the Ministerial statement.

Following the Ministerial announcement, the SAHC sent a copy of the statement by facsimile to all local council authorities, the National Food Authority and to the Meat Hygiene Unit of the Department of Primary Industry.

On Tuesday 24 January 1995 a meeting took place between representatives of the SAHC and Garibaldi. The meeting had been requested by Philip Marchi. A general discussion took place about what was known about the outbreak and what action had been taken to that stage. At the conclusion of the meeting, Mr. Rose provided a copy of the protocol produced by the National Food Authority covering food recalls, and also drew their attention to their obligations under the Trade Practices Act to notify the National Food Authority of the recall. The food recall protocol is Exhibit C.67c NR10. It provides a detailed and helpful set of guidelines as to how a food recall should take place.

Notwithstanding their facsimile message to the Health Commission on 23 January, and their conversation on the 24th, Garibaldi did not cause a recall notice to be placed in the press until Thursday 26 January 1995. Because they were concerned that this was a public holiday, the recall notice appeared again on Friday 27 January.

Mr. Rose says that on 24 January 1995 he telephoned Philip Marchi from Garibaldi and suggested that all mettwurst should be the subject of a recall notice (T.1959), and that Philip Marchi told him that this was under consideration. In evidence, both Neville Mead and Philip Marchi from Garibaldi indicated that on the afternoon of Tuesday 24 January 1995 they decided to recall all mettwurst (T.5219, 5432-3).

On Wednesday 25 January 1995, a further meeting took place at which the SAHC, Garibaldi, the Department of Primary Industry and IMVS were represented. Dr. Stuart Andrews from the University of South Australia was also present.

The notes taken at the meeting (Exhibit C.88j) indicate that an extensive conversation took place about many aspects of the outbreak. During the conversation, the Garibaldi representatives indicated that the proposed recall would extend to all mettwurst with use-by dates between 26 January 1995 and 12 April 1995 (T.1961). A facsimile received from the National Food Authority on that day dated 11.26a.m. confirmed this fact (see Exhibit C.67B NR13).

At that time, there appears to have been some confusion about whether regulation of the meat processing industry was still the jurisdiction of the SAHC and Local Government under the Food Act, or whether that responsibility had passed to the Department of Primary Industry pursuant to the Meat Hygiene Act. During that afternoon, it was clarified that in fact the regulations pursuant to the Meat Hygiene Act had not yet been promulgated, and that the responsibility was still with SAHC.

On Thursday 26 January 1995 there appears to have been no activity on the part of the SA Health Commission since that was a public holiday. As I have already mentioned, the first advertisement appeared in "The Advertiser" newspaper notifying the public of the recall of all lines of mettwurst produced by Garibaldi having use-by dates between 26 January and 12 April 1995.

(c) No mention of Salami

Of particular note is the following sentence in the notice:-

"This recall only affects mettwurst. No other Garibaldi smallgoods products are affected".

 

The same notice appeared again on Friday 27 January.

This is most disturbing in view of the evidence of Ms. Diane Davos of the IMVS who told me that on 26 January 1995 she telephoned Neville Mead of Garibaldi and advised him of the results of testing they had carried out on some samples of mettwurst and salami submitted by Garibaldi for testing on Tuesday 24 January. Of particular importance is the fact that Mrs. Davos informed Mr. Mead that the PCR testing in relation to salami had also proved positive for the presence of SLTEC producing organisms. The IMVS did not notify the Health Commission of this fact since they regarded the information as confidential to their client, Garibaldi. However, she said that she did tell Mr. Mead that she felt that he should inform the SAHC of these results, since she obviously realised the importance of the information to the public health situation at that time (T.3088).

Neville Mead, when questioned about this conversation, while not denying the accuracy of Ms. Davos' recollection, sought to suggest that Ms. Davos simply left it to him as to whether or not the Health Commission should be informed and did not express an opinion one way or the other (T.5266). While the distinction is a subtle one, I accept Ms. Davos' evidence in preference to that of Mr. Mead, as I found his evidence on this topic unconvincing and self-serving. Mr. Mead explained his failure to notify the Health Commission either at that stage or at a subsequent stage, on the basis that the salami that had been submitted for testing to the IMVS, had not been released to the market place and was therefore not a threat to public health (T.5226).

These results were extremely significant for two reasons:-

· they completely invalidated the statement in the recall notice which appeared on that day, 26 January, and the following day, that "no other Garibaldi smallgoods products are affected". Although Mr. Mead somewhat disingenuously suggested that the salami tested had not yet been released to the public, he had no grounds for thinking that the processes by which that particular salami had been made were any different to that which had been previously released to the public;

 

· the fact that salami was implicated indicated that Garibaldi's previous contention, that mutton received from Victoria was the likely source of the contamination, was also dubious, since mutton was not used in the production of salami.

 

On Friday 27 January 1995, a meeting took place at the Garibaldi premises situated at 1250 Old Port Road, Royal Park. Representatives from SAHC, the Department of Primary Industry, City of Hindmarsh and Woodville, and Garibaldi were present. During that meeting, Mr. Rose from SAHC requested information concerning production of mettwurst, and in particular any production records which were available. He also requested any other written material which may have been relevant, such as production manuals and the like. The SAHC officials were informed by Neville Mead, the financial controller of Garibaldi, that any such requests for information should be made in writing through the company's solicitors.

The Garibaldi representatives did not inform the SAHC representatives at that meeting of the fact that salami had also been implicated. The subject was specifically raised by Mr. Rose when questioning the Garibaldi representatives. The notes prepared by Mr. Hobson at that meeting (Exhibit C.67b, NR16) read as follows:-

"How much salami produced? Why have there been problems with mettwurst but have to date have not seen any problems. Is there any variation between processes? Philip Marchi advised that they have gone through the process with CSIRO to determine what could be causing the problem".

 

This directly contradicts Mr. Mead's evidence at T.5229 that the subject of salami did not arise on Friday the 27th. It was the perfect opportunity for either him or Philip Marchi to inform the officers of the Health Commission of those highly relevant results, and yet I find that they deliberately refrained from doing so. I am unable to decide why they did not do so - perhaps it was in order to limit the damage they were already suffering.

Mr. Hobson's note also records that Mr. Rose requested the following documents:-

· current operation procedures of plant;

 

· records for manufacturing process;

 

· records for raw product (meat) - particularly associated with contaminated product;

 

· cleaning requirements;

 

· staff structure - who is responsible for what;

 

· pH, temperature records and people who recorded that - what are acceptable levels?

 

· water quality.

 

This documentation was not provided by Garibaldi until 1 February 1995 (T.2007).

As a result of their lack of knowledge of Garibaldi's processes and procedures, and as a result of the failure by Garibaldi to supply documents requested until 1 February, the SAHC were powerless to provide any meaningful input into the recall process. True it is that they regarded it as a voluntary process, and that they had the impression that Garibaldi were co-operating with them, but, in my view, the SAHC played a far too passive role in the entire process. Had Mr. Rose or one of his staff attended at Garibaldi's factory on Monday 23 January 1995 (as indeed Mr. Clark did), and obtained the information which Mr. Rose requested on Friday 27, they would have been in a position to ascertain that the recall process was far too narrow. Had Garibaldi told them that they needed to seek legal advice, then the Health Commission should have remained on site until that advice was obtained, and their requests complied with. After all, they had the lawful power to do so.

(d) The powers of the SA Health Commission

Section 24 of the Food Act 1985 provides:-

"24(1) An authorised officer may, at any reasonable time, enter and inspect premises to which this section applies.

(2) ...

(3) In the course of carrying out an inspection under this section, an authorised officer may -

(a) ask questions of any person whom he finds in the premises ...

...

(8) A person who -

(a) --

(b) having been asked a question by the authorised officer, does not answer the question to the best of his knowledge, information or belief;

(c) --

shall be guilty of an offence.

Penalty: $5,000.

(9) In this section -

"The premises to which this section applies" means premises used for -

(i) the manufacture or storage of food for sale;".

 

In fairness to the officers from the SAHC, they took the view that the recall process was likely to be more effective if the co-operation of Garibaldi was maintained, and encouraged, not discouraged by overbearing and officious behaviour. I can well understand that a co-operative manufacturer would have made the task of the Health Commission very much easier in relation to the recall process, since it has the relevant knowledge at the start.

However, as things transpired, the Health Commission took far too long to find out what it needed to know in order to gauge whether the recall process was effective or not. This was exacerbated by the fact that the company actively concealed information from the SAHC which was highly relevant to the procedure. As a result, the initial recall process was far too narrow.

If Garibaldi had maintained a refusal to provide information after taking legal advice about the matter on Monday 23, then a decision would then have been required as to whether the recall process should have remained voluntary. The Health Commission had powers under Sections 25 (to prohibit sale, movement or disposal of food and to require the destruction of food), and 27 (to publish warnings to the public where there is a substantial risk that food sold is unfit for human consumption) which were available to them. In my view, the mere indication that those powers might have been used, would have engendered co-operation from Garibaldi. If not, then they should have been resorted to on that day in order to ascertain the information required to assess the recall.

Had the SAHC officers obtained the information they required on 23 January 1995, they would have ascertained:-

· that it was not possible to identify the date of manufacture of any particular sample of Garibaldi product by reference to the use-by date. Not only was this important information for the purpose of determining whether it was useful to specify a use-by date in the recall notice, it was also highly relevant to the question of whether a breach of the Food Standards Code had occurred. That code requires that each "batch" must be identifiable, a batch being defined as an amount of product produced within a 24 hour period. Garibaldi was quite unable to do this.

(see Food Standards Code, Standard A1, Clause 3(a) ).

· because the date of manufacture could not be identified, then the source meat used in the manufacture of the product could also not be identified. Indeed, since a product bearing a particular use-by date could have been manufactured anytime within up to a five week period, a very wide range of source meat may well have been involved. In my view, a prudent health official would have urgently considered a complete recall of all products in those circumstances;

 

· the batch production records would have indicated that the same source meats were used both in mettwurst and salami, apart from mutton and pork meat. The standard operating procedures would also have indicated that the machinery was not usually disinfected between batches of salami and mettwurst (since both were uncooked products). Accordingly, there was a substantial risk of cross-infection which would also have led them to suspect that salami might also be contaminated, and to consider whether it should be included in the recall;

 

· any uncertainty within the Health Commission as to whether mettwurst was cooked or uncooked, and as to whether salami was cooked or uncooked, would have been extinguished;

 

· the records would also have clearly established that there was no quality control procedure in operation at the Garibaldi factory. Accordingly, the monitoring of such vital information as pH, water activity and the like was not occurring as it should have, which would have substantially increased the suspicion that not only mettwurst but salami might have also been contaminated.

 

(e) Further Ministerial announcement

Garibaldi published recall notices in "The Advertiser" newspaper on Thursday 26 and Friday 27 January 1995, which extended the recall from Garibaldi garlic mettwurst with a use-by date of 12 March 1995 (as mentioned by the Minister on Monday 23 January) to include all forms of mettwurst with use-by dates between 26 January and 12 April 1995. It is to be noted, however, that at no stage did the Minister extend his announcement or make any further public announcements about the recall process. Having become involved to the extent that he did on the 23rd, in my view it would have been prudent for a further Ministerial announcement to have taken place, either on Tuesday 24th or Wednesday 25th, to extend the announcement he had made on the 23rd once it became clear that it was too narrow. Although there is no evidence that this would have changed anything, it may have given added emphasis to the widening of the recall.

(f) Publication in languages other than English

The suggestion has been made that the recall notice should have been published in languages other than English, and in print media other than "The Advertiser", so that it reached the non-English speaking members of the community. I note that this topic is presently under consideration in the course of the review of the recall protocol published by the National Food Authority. There is no evidence that anybody failed to hear about the recall as a result of any such omission.

(g) Other Issues arising from the Recall Process

Other criticisms in relation to the recall process included:-

· the Health Commission was advised, in relation to the case of Dana Hutchinson, on about 30 January 1995 that salami had been consumed by the patient. Mrs. Hutchinson telephoned the Health Commission on 31 January 1995 expressing her concern that Garibaldi salami was still on sale at Woolworths at Aberfoyle Park (T.324). Coincidentally, on 30 January 1995 the company had already decided to recall salami products as well as mettwurst, according to Neville Mead (T.5237). However, the further recall notice, which was extended to include "all salamis, prosciutto, parma, pancetta and copocollo with use-by dates between 26.1.95 and 12.4.95", did not appear in "The Advertiser" until Saturday 4 February 1995, and in "The Sunday Mail" on 5 February 1995 (T.5269). The delay in organising the recall of salami on the part of Garibaldi is difficult to understand. As soon as they had the information from Ms. Davos on Thursday 26 January, they should have included salami in the recall;

 

· Garibaldi also overlooked including their generic brands of mettwurst and salami, and salami made for pizza toppings, in the recall (T.5383). The knowledge of these additional products was peculiarly within the possession of the Garibaldi directors, and should have been volunteered to the SAHC during the early days of the recall. I accept that the non-inclusion of these products in the recall was a genuine oversight;

 

· the SAHC had no information about the sales distribution of Garibaldi's products, notwithstanding that this information was available as a computer printout from Garibaldi's records (T.4764). For that reason, the Health Commission had no way of verifying how complete or effective the recall had been.

 

(h) Conclusions

As Mr. Soulio identified in his submissions (at p.48), one danger of a voluntary recall process is that it places the manufacturer in a position where a conflict of interest exists. There is a natural tendency to minimise the economic damage to the manufacturer which may be incurred by the recall process. That is particularly the case where, as here, the entire future of the company was at stake.

In those circumstances, it is my view that the Health Commission should have been more pro-active in the recall process, and exercised a far greater degree of supervision over the company, particularly in determining the width of the recall. The SAHC clearly had the legal power to do so. Ironically, some of the Garibaldi officers were surprised that the Health Commission did not take a more directive role (see the evidence of Neville Mead at T.5352).

11. CHANGES TO LEGISLATION

In April 1995, the National Food Authority published a Code of Hygienic Production for Uncooked Fermented Comminuted Meat Products. This code has been incorporated by amendments to the Food Standards Code and, accordingly, has the effect of legislation by virtue of Regulation 7 of the Food Regulations, 1986, made pursuant to the Food Act 1985.

In the introduction to the code, Dr. Andrew Theophanous, the Parliamentary Secretary responsible to the Federal Minister for Primary Industry in this area, described the code as "an interim measure to protect consumers while industry and government further develop quality assurance and safe food handling principles".

Key provisions of the amendments include:-

· fermentation by mixing with a previously fermented food (back-slopping) is prohibited (clause 60A(2) );

 

· the use of a starter culture is now mandatory (clause 60A(4) );

 

· the pH of fermenting products must be monitored and recorded regularly during the fermentation phase (clause 60A(5) );

 

· compliance with the Code of Hygienic Production for Uncooked Fermented Comminuted Meat Products, which sets out key mandatory elements in the production of smallgoods was also made mandatory (clause 60A (7).

 

The code includes the following further key elements:-

· the AQIS 1992 guidelines, the MATFA Code of Hygienic Practice, and the CSIRO Meat Research newsletter were specifically approved and established as guidelines for hygiene and safety procedures. Although the Code specifies that these reference documents are advisory, it reinforces the fact that the specifications contained in the Code are mandatory;

 

· HACCP systems are also mandatory. The Code lays down minimum requirements for a HACCP system established by the manufacturer covering such issues as receipt and storage, processing, use of starter culture, fermentation, and post-fermentation phases;

 

· the keeping of records of the parameters monitored at each Critical Control Point is mandatory and should be kept for one year after the end of shelf life of a product, or two years, whichever is the greater.

 

If all smallgoods manufacturers comply with this amended code, it is clear that, on the evidence of Dr. Grau and Professor Baumgartner, the risk of a repetition of this outbreak will be substantially reduced. In particular, if a proper and effective HACCP programme is established, the possibility that harmful microbiological activity might not be prevented is substantially reduced.

I will deal, in the next chapter, with the proclamation of the South Australian Meat Hygiene Act, 1994, pursuant to which these requirements will become a condition of the accreditation of meat processors.

The question remains as to whether, even if all these standards are complied with, the problem with food-borne E.Coli infections will disappear. Professor Baumgartner was optimistic:-

"In terms of the technology associated with the particular processes I am firmly of the belief that, providing you undertake adequate controls, establish appropriate control measures, monitor and record those, so that you have the knowledge you can go back to if there are any difficulties, that you are able to produce a product which is safe. That is in terms of my experience to date".

(T.5601).

However, he cautioned:-

"That will, I believe, if it (the HACCP system) is done correctly, be adequate, however, that will make it very difficult for many of the very small manufacturers, the small individual butcher shop, the one-person unit, where that will be much more difficult for them to undertake all these control measures, because it does involve a significant amount of monitoring to ensure that you maintain the correct conditions".

(T.5601).

Dr. Grau agreed, saying:-

"The picture seems to be that if you have a good system from slaughter, chilling, freezing, handling of the meat then if the pathogens are around, they will only be around rarely and in low numbers, and the information still at present would suggest that the fermentation carried out ... properly should control the organism".

(T.5716).

However, he cautioned that there is still a lot of scientific effort going towards trying to establish whether, even with the best procedures, there remains a risk that a recurrence of this tragedy will occur. The framing of future legislation will obviously determine to what extent the present legislative scheme is appropriate. As Dr. Grau remarked:-

"There will certainly be a lot of scientific endeavour put into it".

(T.5717).

12. ENFORCEMENT

The system of enforcement of the Food Act is a complicated one, involving both Local and State Government. It seems to owe more to history and politics than it does to efficiency and clarity.

The Garibaldi factory was situated in the Hindmarsh-Woodville Corporation area, and the person in charge of environmental health in that area was Mr. David Surrell. He gave evidence that he is one of four Environmental Health Officers (EHO's) employed by the Corporation, and they must cover 680 premises in the area (T.3681). He said that they aim to inspect each business twice a year (T.3687), but because there are so many, they divided up the businesses into "A", "B" and "C" categories, with "A" premises receiving less attention.

Mr. Surrell told me that the Garibaldi premises were in the "A" category (T.3691). Routine inspections of the Garibaldi factory took place in 1989, 1993, and 1994, before this outbreak in 1995. There were also visits in relation to particular complaints.

Mr. Surrell confirmed that his officers always gave notice of a routine inspection (T.3702), and he did not seem surprised that this notice would prompt a clean-up at the factory (see the evidence of John Gilbert at T.3530). He said that the giving of such notice was regarded as a courtesy, and that, being Local Government, "customer focus has a high profile" (T.3696).

I must say that I have some difficulty with the concept of a regulatory authority describing the occupier of premises to be inspected as a "customer". I realise that the expression has a certain currency in management jargon at the moment, but it implies a relationship of service which is inappropriate. It is not the function of an EHO to please those whom he or she is required to inspect, although I do not suggest that unnecessary rudeness and officiousness should be resorted to. However, there will be times when the "customer" will be displeased by an EHO's actions, and, in my view, the public has a right to expect that an EHO will not be daunted by that.

Firmness, objectivity and professionalism should govern the activities of a regulator, particularly where, as here, the health and safety of the general public are at stake. I do not consider that the concept of customer service has a role in this context.

The Local Government officers were responsible for the hygiene of processing premises. Although this involves inspections and some testing, they do not focus on the food produced. Mr. Surrell told me that he regarded the Garibaldi factory as "extremely well-maintained" and that he had arranged for students to visit so they could see how things should be done (T.3725).

The officers of the SAHC were responsible for the fitness of food in the marketplace available for human consumption. SAHC officers purchased products from retail outlets on a routine basis and subjected them for analysis.

Mr. Nick Rose explained that testing was aimed not only at whether the food was contaminated, but also whether it contained appropriate ingredients and otherwise complied with the requirements of the Food Standards Code.

Mr. Rose said that routine sampling of mettwurst had no formal structure or programme. He said that they would concentrate on the larger brands (including Garibaldi), although he conceded that a particular brand might be missed for a year or more (T.1915).

A further complication is that the Meat Hygiene Act, 1994, has now established that the responsibility for meat processors (including smallgoods manufacturers) has now passed to the Meat Hygiene Branch of the Department of Primary Industry. That Act applies not only to meat in its ordinary form, but also to:-

"a product intended for human consumption or consumption by pets resulting from a process in which meat is mixed with another substance or is minced, cured, cooked, salted, fermented or otherwise treated ...".

(Section 3).

The Act sets up a system whereby meat processors must be accredited (Section 12), and the accreditation process will include not only a check of the hygiene conditions at the factory, but also an oversight of a quality assurance programme which has been approved (Section 16(1)(e) ). Meat Hygiene officers have been granted wide powers of entry, inspection, sampling, control of movement of stock, seizure, to require answers to questions, and to give directions (Section 29).

On 25 January 1995, there was some confusion about whether this transfer of responsibility had already occurred (Rose, T.1967). However, it was established that it had not. In any event, the SAHC retains responsibility for the fitness of food once it has left the factory, and also retains a responsibility to supervise the recall process (T.1967).

It would appear that the role of Local Government will be substantially reduced in future in relation to premises where meat and meat products are processed, so this may take some of the load from EHO's and enable them to police other food production premises more stringently.

I have already referred to the wide powers contained in the Food Act, and that following the Gallichio and Pisani incidents in 1991 and 1992 respectively, these powers were not used effectively. These incidents did not even cause the SAHC or Local Government to pay closer attention to Garibaldi's premises, or to monitor their product more closely.

I have already mentioned that, had the requirements of the Food Standards Code in relation to labelling, and the traceability of batches, been effectively enforced, the recall process after this outbreak would have been much more effective.

Mr. Rose admitted that, although it was an SAHC responsibility, such requirements of the Code were not commonly investigated (T.2031). Dr. Kirke, the Director of the Public and Environmental Health Branch of SAHC, said:-

"The resource implications of enforcing those aspects of food law are horrendous. Yes, it has been ineffectively policed, and it would be very nice to be able to police it more effectively".

 

In my opinion, this case demonstrates that it is essential that the food law is enforced effectively, and that health authorities are adequately resourced for the purpose.

(a) Conclusion

The legislative provisions which have now been put in place, particularly the amendments to the Food Standards Code, and the Meat Hygiene Act, represent a rigorous and appropriate response to the issues which have arisen from this inquest. The progress being made in such areas as quality control, HACCP programmes, and the on-going consideration of complex issues as the setting of standards for coliform concentrations on meat, is to be applauded.

However, all of these developments will be useless unless they are thoroughly and rigorously enforced. Of course, the co-operation of industry is important in implementing these changes. I am sure that this co-operation will be forthcoming when manufacturers realise, as Mr. Wintulich has, that quality assurance or HACCP programmes will not only ensure safety, but will confer advantages to them in the form of consistency and predictability of product, the ability to meet detailed specifications stipulated by trade customers, and an improvement in the general reputation of their product.

In the event that some manufacturers do not embrace these modern developments, and find themselves in breach of the legislated requirements, they should be left in no doubt that they will be prosecuted energetically. The requirements of public health are too urgent, as this case has tragically demonstrated, for half-measures in enforcement of food legislation.

Enforcement authorities must be adequately resourced so that they can fulfil that role.

13. RECOMMENDATIONS

Pursuant to Section 25(2) of the Coroners Act I am empowered to make such recommendations as will in my opinion prevent or reduce the likelihood of a recurrence of this tragic event. I make the following recommendations, the reasons for which will be apparent from the text of these findings:-

1. That the Minister of Health and the SAHC consider whether it is possible to arrange a reliable system whereby information about communicable disease outbreaks might be disseminated to medical practitioners on a quick and efficient basis, and consider whether subscription to such a system might be made a pre-condition to registration to practise medicine in South Australia.

 

2. That SAHC review its practices in relation to the follow-up of incidents where a breach of the Food Standards Code has been established or suspected, to ensure that the monitoring of a particular manufacturer is sufficiently close that there can be assurance that the problem has been rectified.

 

3. That the National Food Authority establish a standard for the presence of coliform bacteria on meat to be used in the manufacture of uncooked fermented smallgoods. Such a standard should set a maximum level at which a properly monitored and scientifically validated manufacturing process will be capable of eliminating all remaining coliform bacteria. A standard might also prohibit the presence of SLTEC's in the finished product, as is presently the case with salmonella.

 

4. That the SAHC take steps to ascertain whether there is a faster method by which information about other outbreaks of communicable diseases might be disseminated, rather than relying on what is a rather slow and cumbersome facility provided by the Morbidity and Mortality Weekly Report.

 

5. That the SAHC review its internal procedures whereby information available to certain of its officers (e.g. the Food Standards Section) might also be available to the epidemiologists during the investigation of an epidemic.

 

6. That the SAHC review its procedures in relation to the preparation of questionnaires, ideally by having them prepared and ready for particular outbreaks, with a facility for updating them as new information becomes available. In any event, preparation of questionnaires should take place under the supervision of qualified epidemiologists.

 

7. That the SAHC review its procedures in relation to the interview of relatives of people who have become ill during an epidemic, particularly to ascertain the attitude of such people to being interviewed at the hospital, and generally to devise ways of arranging the interviews more urgently.

 

8. That the SAHC review its procedures in relation to the analysis of data collected during an epidemiological investigation, so that a formal scientific process of analysis takes place as soon as, and as often as, such information becomes available.

 

9. That the Minister of Health consider amendments to Section 30 of the Public and Environmental Health Act:-

. to make notification mandatory when a medical practitioner believes a person may be suffering from a notifiable disease;

. to review the five day limit for notification;

. to make HUS and TTP notifiable diseases.

 

10. That the SAHC reconsider its policies and procedures in relation to voluntary recalls. While it was not necessary for them to have taken over the recall completely, officers of SAHC should have satisfied themselves at the outset, on 23 January 1995, that it was wide enough to ensure public safety, and should have exercised much greater supervision over Garibaldi during the recall process. If Garibaldi had failed to co-operate, reconsideration should have been given to whether the process remained voluntary.

 

11. That the SAHC reconsider its policies and procedures in relation to the powers held by authorised officers pursuant to the Food Act, and implement training and development programmes which equip its officers to take a more pro-active and rigorous approach to the enforcement of the food legislation.

 

12. That the Minister of Health, in consultation with the Minister for Primary Industry, and with the relevant departments, and with Local Government, conduct a review of the resources available in the area of enforcement of food legislation (the term resources extending to human resources, training, development, and physical resources) to the intent that the legislation presently in place can be rigorously and effectively enforced.