E v Australian Red Cross Society

Re: E
And: AUSTRALIAN RED CROSS SOCIETY; AUSTRALIAN RED CROSS SOCIETY NEW SOUTH
WALES DIVISION and CENTRAL SYDNEY AREA HEALTH SERVICE
No. G759 of 1989
FED No. 20
Trade Practices - Negligence
(1991) 13 ATPR 41-085
99 ALR 601
27 FCR 310

COURT

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY
GENERAL DIVISION
Wilcox J.(1)

CATCHWORDS

Trade Practices - Supply by hospital to applicant of HIV- infected blood - Blood supplied to hospital by New South Wales Division of Australian Red Cross Society - Whether respondents were each a "trading corporation" - Whether supply "in trade or commerce" - Whether the hospital was an emanation of the New South Wales Crown - Claim of implied misrepresentation amounting to misleading conduct - Reliance on implied terms as to merchantability and fitness for disclosed purpose - Whether claims made within the prescribed time.

Negligence - Adequacy of screening notices used by NSW Division in collecting blood donations - Whether respondents should have adopted surrogate testing at earlier date - Time taken to implement decision to adopt surrogate testing.

Trade Practices Act 1974 - ss4, 4B, 52, 55A, 71, 74, 82.

HEARING

SYDNEY

#DATE 8:2:1991

Counsel for the Applicant: J. Poulos, QC and M. Cashion

Solicitors for the Applicant: J.M. Caruana Kay and Barry

Counsel for the 1st Respondent: L.M. Morris, QC, J.A. Timbs, QC and A.

Robertson

Solicitors for the 1st Respondent: Arthur Robinson and Hedderwicks

Counsel for the 2nd Respondent: T.K. Tobin, QC, P. Dwyer and A.

Robertson

Solicitors for the 2nd Respondent: Tress Cocks and Maddox

Counsel for the 3rd Respondent: P.R. Garling and R. Gambi

Solicitors for the 3rd Respondent: Audrey Lee

Counsel for Attorney General P. Taylor
(NSW) Intervening:

Solicitor for Attorney General Crown Solicitor
(NSW) Intervening:

ORDER

The Application be dismissed.

The applicant pay to the respondents their costs of the proceeding.

Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

JUDGE1

This case concerns one of the major health problems of our time: acquired immune deficiency syndrome ("AIDS"). It is a tragic case, of AIDS contracted by the recipient of a post-operative blood transfusion. Because of its contamination, the transfusion which saved the applicant's life in 1984 threatens now to shorten his life.

The AIDS cases generally

Before dealing with this particular case, it is desirable for me to say something about the large number of AIDS claims now confronting the Court.
During the afternoon of 8 November 1989 an application was made to me in chambers by counsel and his instructing solicitor. The solicitor was about to file 30 Applications, on behalf of 30 separate clients, each seeking damages from the Australian Red Cross Society ("the Society"), the New South Wales Division of that Society ("the NSW Division") and one or more other respondents. Each of the proposed applicants, I was informed, was a person infected with the human- immuno deficiency virus ("HIV") who claimed to have become so infected as a result of receiving whole blood, or one or more products made from whole blood, garnered from donors at a blood bank operated by the NSW Division. Counsel asked that, in each case, I make an order under s.50 of the Federal Court of Australia Act 1976 prohibiting publication of the name of the applicant. He gave as his reason the stigma which, in our community, still attaches to persons who are known to be HIV positive and the likely prejudice and embarrassment to the applicants and their families of any publicity about the proceedings. I acceded to the request, reserving until the trial of each matter the position which should then apply.
The 30 Applications were filed on the day the confidentiality order was made. Subsequently, a further 12 similar Applications were filed. The same confidentiality order was made in respect of these matters. At the directions hearings the matters were listed as "Various applicants v Australian Red Cross Society and others", references being made to the proceeding number where it was necessary to distinguish one case from the others. The 42 cases presented the Court with a management problem. It was obviously impossible to expect the parties' advisers to prepare all matters for trial simultaneously. But because the life expectancy of people infected with HIV is considerably less than normal, it was especially important to expedite the final disposal of the cases.
One of the cases was dismissed by consent. The remainder are unconcluded. They have many features in common. In each case, reliance is placed upon provisions in the Trade Practices Act 1974. With minor exceptions, in each case all the respondents dispute the application of those provisions. They deny that they are corporations to which the Act applies and also that the supply of blood to the various applicants was an act "in trade or commerce". By a notice of motion heard on 5 April 1990, an application was made for trial of those questions as preliminary issues. I refused that application, taking the view that this course would cause unnecessary delay in the final resolution of the cases; particularly if there was an appeal against the decision on the preliminary issues. I had in mind that, irrespective of the application of the Trade Practices Act, there were other causes of action relied upon by each applicant, notably negligence. These issues would, in any event, require an investigation of many of the facts which were relevant to the Trade Practices Act claims. On 1 May 1990 the Full Court refused the respondents' application for leave to appeal against my decision on the notice of motion.
The legal issues concerning the application of the Trade Practices Act are not the only common features of the various claims. Fundamental to each is the sufficiency of the steps taken by the respondents, especially the Society and the NSW Division, to protect the donated blood supply from HIV contamination. In particular, questions arise in each case as to the adequacy of the steps taken to screen donors - by such means as notices, questionnaires and interviews - and whether hepatitis B surrogate testing ought to have been adopted earlier or more widely. In the present case these issues have generated a considerable body of evidence. But the evidence stops at October 1984, the month of the subject donation and transfusion.
If there were in force in this Court provisions relating to grouped proceedings, such as those recommended by the Australian Law Reform Commission in its report "Grouped Proceedings in the Federal Court" (ALRC 46), it would have been possible for the Court to determine all common questions of fact or law at a single hearing in such a manner as to make the result binding on all applicants and all respondents. Those questions could have included not only the Trade Practices Act issues but also, with very little additional evidence, the issues regarding screening and surrogate testing at dates after October 1984. The result would have been to avoid the repetition in each of the later cases of most of the evidence in this case, with consequential savings in costs and the earlier finalisation of the whole litigation. But that recommendation has not become law. So it will be necessary to deal with each of the cases separately. Perhaps the parties in the later cases will choose to be bound by the ultimate result of the present case, in respect of relevant issues. To that end and even though it may be strictly unnecessary to do so, I propose to make findings on all of the issues of fact and law which were litigated in this proceeding.
Despite the common elements in the claims, there are differences in the circumstances under which the various applicants, on their allegations, became HIV infected. Some applicants claim to have become infected as a result of a single post-operative or post-parturition transfusion. Some claim to be haemophiliacs who have received blood products on numerous occasions. The applicant whose case was discontinued, and who has since died, was an infant infected as a result of breast feeding by her mother, who had received the virus in a post-parturition transfusion. Moreover, the date at which the particular applicants allegedly received the blood or blood product is an important matter. Most, if not all, claims relate to donations received during the years 1983, 1984 and 1985. During this period there was a steady growth in scientific knowledge about the virus and in awareness, both in scientific circles and amongst the public generally, of the devastating nature of its final form, category 1 or "full" AIDS. During this period the NSW Division made changes to its screening and testing procedures in order to reduce the likelihood of HIV contamination. The adequacy of those changes is a matter of controversy in this proceeding. At this stage, I merely make the point that it is impossible to evaluate these cases - at least the claim of negligence in each of them - without paying careful attention to the date or dates of the relevant donation or donations.
The increase in knowledge and awareness did not stop in 1985. The danger of applying hindsight occurs in most litigation; but it is particularly pertinent to these cases. Since the relevant dates there has been a significant advance in the scientific understanding of AIDS, combined with massive publicity in the popular media. Everyone involved in this case has had constantly to remember the necessity of going back to the circumstances applicable at the time of the subject donation, as revealed by the evidence.
The issues
The legal issues in this case are complex. They have caused the parties to adduce a considerable body of detailed evidence. My account of that evidence must necessarily be lengthy. In the hope that it may assist an understanding of the significance of matters mentioned in that account, I immediately summarise the issues raised between the parties.
The claim of the applicant is that, on 12 October 1984, there was administered to him at The Royal Prince Alfred Hospital, Sydney, a transfusion of fresh frozen blood plasma which was HIV infected. He brings his claim against three respondents: the Society, the NSW Division and the Central Sydney Area Health Service. As their names suggest, the first and second respondents are closely related; the second respondent is actually a component of the first respondent. Yet each is a separate corporate entity capable of being sued in its own name. The applicant claims that the Society is responsible for, and supervised, the blood collection activities of the NSW Division. This claim is not admitted. The applicant further claims that the NSW Division at material times engaged in the collection and fractionation of blood and its distribution to The Royal Prince Alfred Hospital, a claim which is, in substance, admitted. The applicant further claims that each of the Society and the NSW Division was, at material times, a "trading corporation" within the meaning of the Trade Practices Act. This claim is contested by each respondent. The issue thus created is critical to the question whether the provisions of that Act are available against those respondents. It has caused the tender of a considerable body of evidence concerning the nature, history and operations of those two respondents.
The Central Sydney Area Health Service did not exist in October 1984. It was created by legislation enacted in 1986. But that legislation made the Service responsible for the liabilities of a corporation which was then dissolved: The Prince Alfred Hospital. So the critical question, insofar as this respondent is concerned, is the liability of the abolished corporation. As to that matter, the applicant says that the abolished corporation was also a 'trading corporation' - a proposition which is denied. Furthermore, this respondent says that the abolished corporation was an emanation of the Crown in right of the State of New South Wales; so that, in any event, it was not bound by the Trade Practices Act. Once again, these issues have resulted in a deal of evidence regarding the hospital, its history, finances and activities. For convenience, I will use the term "the respondents", in some contexts, so as to include The Prince Alfred Hospital.
The allegation that the applicant became HIV infected as a result of the blood transfusion was not admitted on the pleadings. But it was not actively contested at the trial. However, the respondents disputed each of the bases of liability advanced against them by the applicant.
As against all three respondents, the applicant alleges negligence. Although the matter was pleaded in wider terms, in their opening address counsel for the applicant confined themselves to two heads of negligence. First, they said that the procedures adopted by the NSW Division for the exclusion from the blood donor pool of persons within the known AIDS high risk categories were inadequate. In particular, they criticised the form of the warning notice given to donors, the failure to provide face-to-face questioning and counselling of donors and the lack of any system permitting an embarrassed donor anonymously to request the discarding of his or her donation.
Secondly, conceding that no specific test for HIV infection was then available, counsel contended that the first and second respondents ought, by the date of the donation, to have had in place a surrogate test, for hepatitis B core antibodies ("anti-HBc"), which would have identified many of those persons in high risk groups who gave blood despite the warning. They said that, if an anti-HBc test had been applied to the donation which infected their client, that donation would probably have been discarded and the infection avoided. Counsel suggested that the Society is answerable for the negligence of the NSW Division; either on the basis that the NSW Division is part of the Society, so that the acts of the Division are the acts of the Society, or on conventional agency principles. Each of the contentions of negligence is contested by counsel for the Society and the NSW Division.
It is not suggested that the hospital had anything to do with the collection of the blood donation or its processing into fresh frozen plasma. The claim against the hospital is that it was negligent in transfusing the plaintiff with blood plasma which had not been collected in accordance with proper procedures, as identified in the submissions already mentioned.
The applicant also relies on a series of representations said to have been made to him on behalf of the various respondents. I will set them out later. For the moment, it is enough to say that counsel for the applicant do not suggest that any express representations were made. They say that the representations were implied by the circumstances of the transfusion. They seek to use those representations to support three claims: negligent misrepresentation, that the various respondents engaged in misleading conduct in breach of s.52 of the Trade Practices Act and that they engaged in conduct that was liable to mislead the public as to the nature, characteristics or suitability for its purpose of the plasma, in breach of s.55A of that Act. The last two claims each raise the question whether the respondents, or any of them, acted "in trade or commerce" in making any relevant representations; only conduct in trade or commerce is caught by these sections.
Finally, the applicant relies on two sections of the Trade Practices Act, ss.71 and 74, which imply into certain types of contacts particular conditions and warranties regarding merchantability and fitness for purpose. The applicant says that these sections apply to his case and that the respondents, or one or more of them, breached those implied terms. Alternatively to s.71, the applicant relies on s.19 of the Sale of Goods Act 1923 (NSW).
More than three years elapsed between the date of the transfusion and the commencement of the proceeding. Pointing to s.82(2) of the Act, the respondents say that the claims under the Trade Practices Act are made out of time. There is no suggestion that the common law claims are statute-barred.
At one stage of the proceedings one of the respondents thought that a question might arise as to the meaning of "trading corporation" in s.51(xx) of the Constitution. Accordingly, notice of the case was given to the various Attorney Generals pursuant to s.78A of the Judiciary Act 1903. Only the Attorney-General for New South Wales chose to intervene. He appeared by counsel to put submissions regarding the meaning of "trading corporation" in the Trade Practices Act. Counsel argued that, as the meaning of this term in the Act was the same as that in s.51(xx), any question regarding construction of the statutory definition was a matter involving the interpretation of the Constitution. I have reservations about this process of reasoning; but nonetheless I was happy to accept the proffered assistance of counsel in connection with the meaning of both "trading corporation" and "in trade and commerce". I will not normally need to refer separately to those submissions. They were generally consistent with the submissions made by the respondents and may be considered in that context.
The nature of AIDS
AIDS is a condition in which the body's immune system is seriously weakened, rendering the person vulnerable to diseases which he or she would normally fight off. It is now known that the condition is caused by a virus, originally called human t-lymphothatic virus-3 (HTLV-3) but now generally referred to as HIV. It is also known that this virus affects people in different ways. In the incubation stage there may be little or no effect upon the general health or feeling of well-being of the patient. Even today, when there is a reliable test for the presence of the virus, the virus will not normally be detectable for some two to four months after infection. At one stage it was thought that any HIV infection would progress to full AIDS within a very short period, perhaps no more than a year or so. But it is now known that this does not always occur. A small proportion of the persons known to have contracted HIV in the early 1980's still do not exhibit any serious symptoms. Some patients with HIV infection exhibit the lymphadenopathy syndrome, sometimes called "the AIDS-related syndrome". The immune system is impaired, but not so completely as for full AIDS, and the effect is not so devastating. The patient may or may not go on to develop full AIDS.
The major characteristic of full AIDS is that, because of the collapse of the immune system, the patient develops an opportunistic infection which causes a debilitating, and ultimately fatal, illness. These illnesses include an otherwise unusual form of pneumonia, Pneumocystis carinii pneumonia, a rare cancer, named Kaposi's sarcoma, a form of herpes known as cytomegalovirus infection and premature senile dementia. As I understand the position, death usually ensues within about two years of the onset of full AIDS, although there is now reason to believe that the drug AZT may extend this period.
AIDS in America
The occurrence of AIDS has been monitored since 1981. In the developed world, at least in the period to October 1984, the country most affected by the virus was the United States of America. Much of the research regarding the disease was performed in that country and it is common ground between the present parties that Australians charged with the duty of combating the virus looked to, and were entitled to look to, United States' scientific knowledge and experience. Parties on both sides of the record called a United States' expert witness and relied on United States' publications. So it is useful to attempt a brief account of the evidence regarding the position in that country.

The bundle of extracts from scientific publications which has been tendered in evidence includes some early articles discussing occurrences in America of infections which are now known to be associated with AIDS: see "Prevalence of Cytomegalovirus Infection in Homosexual Men", Journal of Infectious Diseases, February 1981; "Pneumocystis Pneumonia - Los Angeles", Morbidity and Mortality Weekly Report ("MMWR"), 5 June 1981; "Kaposi's Sarcoma and Pneumocystis Pneumonia Among Homosexual Men - New York City and California", MMWR 4 July 1981; "Kaposi's Sarcoma in Homosexual Men - A report of eight cases", The Lancet, 19 September 1981. But, so far as the evidence reveals, the earliest article in which a link was made between these illnesses and immune deficiency was one published in the issue of "The New England Journal of Medicine" ("NEJM") of 10 December, 1981. This article, entitled "Pneumocystis Carinii Pneumonia and Mucosal Candidiasis in Previously Healthy Homosexual Men - Evidence of a new acquired cellular immunodeficiency", described four case histories. The authors noted that each patient had a marked imbalance of peripheral-blood T-cell subsets. The normal ratio of T helper cells to T suppressor/cytotoxic cells was inverted. In the light of later knowledge, there is little doubt that the patients described in this article were suffering from what now would be described as full AIDS.
"The Lancet" of 12 December 1981 contained an editorial note, headed "Immunocompromised Homosexuals", which noted that the Centers for Disease Control ("CDC") in Atlanta, Georgia, were currently aware of nearly 180 cases of Kaposi's sarcoma and/or pneumocystis pneumonia "and the numbers are increasing at 7-10 a week". The note went on:

"The epidemic seems to be largely confined to urban areas of New York and California. Most of the patients are young white males (95% aged less than 50) and 94% of them are homosexual or bisexual. The case fatality rate, due to the effects of the tumour or overwhelming infection, has been an alarming 40%".

The note went on to refer to the reversal of the normal ratio of T helper to T suppressor cells in the patients suffering cytomegalovirus infection.
Over the following year or two, there was a plethora of learned articles describing aspects of the new disease. It is not necessary to refer to them individually. But it is interesting to note a comment in the 21 May 1982 edition of MMWR regarding the incidence of lymphadenopathy among homosexual males. The author did not connect that condition to the more serious illnesses previously reported. However, by the end of the year, it was realised that all of those illnesses were related, in this context; and the name "acquired immune deficiency syndrome" was being used to describe the new disease. The 10 December 1982 issue of MMWR contained a report of a possible transfusion-associated case of AIDS, the patient being an infant transfused during the first month of his life with blood donated by a male donor who had since died of AIDS type infections. An editorial note was added to the report:

"The etiology of AIDS remains unknown, but its reported occurrence among homosexual men, intravenous drug abusers, and persons with hemophilia A suggests it may be caused by an infectious agent transmitted sexually or through exposure to blood or blood products. If the infant's illness described in this report is AIDS, its occurrence following receipt of blood products from a known AIDS case adds support to the infectious-agent hypothesis."

The note concluded with a comment that the report, and continuing reports of AIDS among persons with haemophilia, "raise serious questions about the possible transmission of AIDS through blood and blood products. The Assistant Secretary for Health is convening an advisory committee to address these questions".
This committee met in January 1983. At about that same time, NEJM quoted a report from CDC of three cases of AIDS amongst haemophiliacs. The deliberations of the advisory committee were reported in the "Journal of the American Medical Association" ("JAMA") of 4 February 1983 under the heading: "Preventing AIDS transmission: should blood donors be screened?" The report included a reference to two adults "who may have acquired AIDS through whole blood transfusions during surgery". But its main function was to record the views expressed at the committee meeting. Some people expressed doubt whether AIDS was transmissible by whole blood transfusion, some were not even sure that haemophiliacs receiving factor VIII concentrate were in danger. But, according to the report: "Many public health officials ... were convinced that there is a risk, although its magnitude cannot yet be estimated, and that swift action must be taken".
However, JAMA reported that "(w)hen it came to recommending preventative measures ... disagreement was strong". One of the possibilities which was mentioned was a "laboratory test, such as measurement of antibody to hepatitis core antigen, that will identify persons at high-risk of having AIDS". Another was "asking all persons in high-risk groups donating blood to identify themselves so that their plasma could be excluded from factor VIII preparations". The rationale of the first suggestion - which is one pressed by the applicant in this case - was explained in the report:

"Since there currently is no test to detect persons with AIDS or its prodromal illness, another approach is to see whether any test will detect a person at increased risk of having AIDS.

CDC immunologist Thomas Spira, MD, described the results of evaluating several such 'surrogate' tests in persons with AIDS or its prodromal illness. The most successful was measurement of antibody to hepatitis B core antigen. The reason: Hepatitis B is prevalent in the same populations that are at high risk for AIDS. Antibody to core antigen remains elevated even after recovery from acute hepatitis B, so it identifies all persons who have had hepatitis.

This test yielded positive results in 90% to 100% of AIDS patients in various groups (homosexuals, IV drug abusers, Haitians). Results also were positive in 80% of persons with lymphadenopathy, a prodrome of AIDS. In contrast, among first-time contributors to a voluntary blood bank, results were positive in 5%. Spira said the assay could be introduced into routine laboratory testing. There is only one manufacturer of commercial kits, however, and some people wondered whether the supply of reagents could be increased rapidly. Others thought this would not be a major problem."

Reference was made to cost factors and the difficulty of explaining to "those 5% of the normal population who will be positive for anti-HBc ... (that) their blood is no good, but they're healthy". Under the heading "Excluding High-Risk Plasma ... or Trying to" the report recorded a variety of views about the reasonableness and practicality of asking homosexual blood donors to identify and exclude themselves. There was no consensus at the meeting. As the report put it: "Faced with these conflicts, CDC officials returned to their offices to try to devise recommendations".
However, agreement was reached amongst a different group of people, representing the American Association of Blood Banks, the American Red Cross and the Council of Community Blood Centers, with assistance from the American Blood Commission, National Gay Task Force, the National Hemophilia Foundation and representatives of the American Blood Resources Association, CDC and the Food and Drug Administration ("FDA"). That group issued a joint statement on 13 January 1983, which was published in the March-April issue of "Transfusion". It contained seven recommendations. They included donor screening, including specific questions to detect possible AIDS or exposure to patients with AIDS. "In particular, all donors should be asked questions designed to elicit a history of night sweats, unexplained fevers, unexpected weight loss, lymphadenopathy, or Kaposi's sarcoma." But the statement stopped short of recommending questions about sexual preferences and habits, the exclusion of members of high risk groups or surrogate testing:

"6. A major area of concern is whether attempts to limit voluntary blood donation by individuals from groups with a high prevalence of AIDS are appropriate at present. This question has medical, ethical, and legal implications.

a. The presently available medical and scientific evidence that AIDS can be spread by blood components remains incomplete. Fewer than 10 cases of AIDS with possible linkage to transfusion have been seen despite approximately 10 million transfusions per year. Ongoing epidemiologic studies of all cases of AIDS are being conducted at this time. Should evidence of a clearly implicated donor population become apparent, specific recommendations to the blood banking community will be made promptly.

b. There is currently considerable pressure on the blood banking community to restrict blood donation by gay males. Direct or indirect questions about a donor's sexual preference are inappropriate. Such an invasion of privacy can be justified only if it demonstrates clear-cut benefit. In fact, there is reason to believe that such questions, no matter how well-intentioned, are ineffective in eliminating those donors who may carry AIDS.

7. While there is no specific test for AIDS, there are laboratory and clinical findings that are present in nearly all AIDS patients. The use of these non-specific markers - for example, lymphopenia, immune complexes, and anti-HBc - are being evaluated in those areas of the country where AIDS is prevalent. We do not advise routine implementation of any laboratory screening program for AIDS by blood banks at this time."

Neither CDC nor its advisory committee ever made a recommendation in favour of surrogate testing. But in March 1983 CDC called on blood collecting agencies to request that "members of high-risk groups, including sexually active homosexual or bisexual men with multiple partners, voluntarily refrain from donating blood." The June issue of "The Journal of Anesthesiology" reported that these recommendations "were accepted quickly by the blood collecting sector, and appropriate measures for voluntary screening now are in place in almost all areas of the country".
As 1983 went on, the AIDS articles in the medical literature continued: studies showing the incidence of AIDS amongst intravenous drug abusers, blood product recipients, haemophiliacs, children in high risk households and the female sexual partners of AIDS infected men and reports of the relationship between abnormal T-cell ratios and the incidence of AIDS. Sometime between March and May 1983, the Stanford Medical School Blood Center, a centre associated with the School of Medicine at Stanford University in California, introduced the first surrogate testing program for AIDS. This was done at the instance of Professor Edgar Engleman, the Director of the centre and the Associate Professor of Pathology and Medicine within the university. Professor Engleman chose not to adopt anti-HBc tests, but rather a test which measured the ratio between the T4 and T8 cells. In evidence in this case he explained why he took that course:

"We felt that the T cell abnormality was in all likelihood resulting from the disease itself, from the condition itself. In contrast we thought the hepatitis B core antibody test positivity was a lifestyle reflection, if you will."

But he explained that Stanford had special advantages in deciding to adopt the T4:T8 test:

"...we had a substantial research effort and interest in white blood cells, human white blood cells and we had the machinery, the equipment, the technologist to do that test. Once the decision was made we were able to institute it within a matter of days."

Nonetheless, Professor Engleman saw value in anti-HBc

tests for other blood banks:

"I think for most blood banks whether they are larger than ours or not the hepatitis B core antibody test was more practical. It utilized equipment that was on hand already. At most blood banks it used a format technology that was already a common place in blood banks. It was quite similar to the pre-existent hepatitis B surface antigen test so the technologists really needed minimal additional training. Reagents were available commercially; it is a semi-automated test relatively inexpensive and lastly it could be performed on blood that was not fresh. The T cell test required blood that was less than three days old. Q. When consideration of costs was taken into account what was the differential between the T4T8 and the hepatitis B core antibody test in 1983? A. Well, we estimated the cost of the T4:T8 test to be approximately $6 per blood component derived from a donation, roughly $12 to $15 per donor, if you will. The hepatitis B core antibody test was for the testing, reagents equipment and the like was probably $2 or $3 per test."

Consistently with his opinion, Professor Engleman pressed other blood banks to introduce anti-HBc surrogate testing. The Stanford Medical School Blood Center was not able to supply all of the blood required at the Stanford University Hospital, with which Professor Engleman was also associated. The remainder came from the Peninsula Memorial Blood Bank and the American Red Cross blood bank in San Jose. Beginning in October 1983, Peninsula Memorial Blood Bank sent about half the blood it supplied to Stanford University Hospital to the Stanford Medical School Blood Center for T4:T8 testing. This was all that the centre could take. But this was only a temporary measure. As from 1 April 1984 the Peninsula Memorial Blood Bank applied an anti-HBc test to all blood. The American Red Cross blood bank at San Jose took a similar course at about the same time, so that, thereafter, all the blood used at Stanford University Hospital was surrogate-tested.
The issue of NEJM of 8 September 1983 published an editorial article by Dr James Curran of CDC headed "AIDS - two years later". This article contained the information that, by August 1983, a total of 2,008 United States' AIDS cases had been reported, using as the criterion the otherwise unexplained presence of one or more of the "marker" conditions such as Kaposi's sarcoma and Pneumocystis carinii pneumonia. Dr Curran said:

"Most of the patients in the United States fit a pattern with regard to suspected risk factors: 1429 (71 per cent) were homosexual or bisexual men, 339 (17 per cent) were men or women who abused intravenous drugs, and 15 (1 per cent) were patients with hemophilia. Of the other 225 patients with AIDS (11 per cent), 105 were Haitians, 20 were heterosexual sexual partners of persons in an AIDS risk category, and 19 were adults without other identified risk factors who had received blood or blood products within five years before their illness. None of the donors of the blood involved in the last-mentioned cases have been reported to have AIDS, but further investigations are underway."

In this article, Dr Curran referred to the "widespread acceptance of the hypothesis that AIDS is caused by a transmissible agent". But the identity of that agent was still unknown.
Two months later, in November 1983, a French scientist, a Dr Montagnier, spoke at a meeting in Geneva convened by the World Health Organisation. He presented what one listener, Professor Ian Gust, the then Director of the Virus Laboratory at Fairfield Hospital, Melbourne, described in evidence in this case as "the first tentative evidence that he had identified the agent responsible for AIDS". But, Professor Gust said, there was no consensus at the meeting that Dr Montagnier had been successful. So a program of confirmatory research was commenced in the United States under the leadership of a Dr Gallo.
In the meantime, the surrogate testing debate continued. It seems that Professor Engleman was a leading participant. At a number of meetings in the latter half of 1983 Professor Engleman argued for anti- HBc surrogate testing. These meetings included a large meeting convened by FDA in Bethesda, Maryland on 15 and 16 December 1983. But, although some other speakers favoured anti-HBc testing, many were opposed. They thought that the degree of correlation between anti-HBc positivity and being at high risk of carrying the putative virus was insufficient to justify the tests. Some speakers were concerned that the results could be misleading. Some were worried about the costs of an anti-HBc screening program; both financial cost and the waste of usable blood. (Blood is not unsuitable for transfusion or processing into blood products merely because it contains hepatitis B core antibodies. It was accepted on all sides that many people who tested anti-HBc positive would not in fact be HIV carriers.) No consensus was reached at the meeting. At no stage did FDA make any recommendation in favour of surrogate testing.
The 12 January 1984 issue of NEJM focussed its attention upon the relationship between AIDS and blood transfusion. The journal published a study by a team of researchers, led by Dr Curran, regarding 18 adults without other risk factors in whom AIDS had developed after transfusions. The researchers pointed out that these cases represented only about 1% of the United States' AIDS cases reported over the same period, approximately one year. But they also observed that "most of these patients received their transfusions between 1979 and early 1982, a time when the prevalence of AIDS - and presumably of donors affected by the putative AIDS agent - was much lower than during late 1982 and early 1983".
The journal also published, in the same issue, an editorial comment by Dr Joseph Bove, Director of the blood bank at the Yale University School of Medicine. It was entitled "Transfusion-Associated AIDS - A Cause for Concern". Although he noted the absence from the Curran paper of any information about what happened to recipients of other blood components from the suspect donors - most donations are divided into components administered to different patients - Dr Bove did accept that "Curran's data provide substantial evidence that transfusion-related AIDS does occur". He noted the steps already taken to exclude high risk donors and emphasised the importance of physicians weighing carefully the necessity to administer blood. But, otherwise, Dr Bove made no recommendations. In particular, he said nothing about surrogate testing which - we know from the evidence of Professor John Dwyer, who was then his colleague at Yale - he did not favour.
Others shared Dr Bove's view. The division of opinion about surrogate testing which had characterised the FDA December 1983 meeting also occurred in the deliberations of a working group set up by the Council of Community Blood Centers to review the issues there discussed. The study group included representatives of the commercial and non-commercial fractionation industry, the plasma pheresis community, non-profit blood collection and processing organisations and FDA. In a statement published on 16 March 1984 the Chairman of the study group said, amongst other things:

"The study group was divided in its position on testing for anti-HBc as a means of identifying AIDS high risk group members, with the majority believing that such testing was not appropriate for that purpose. However, members of the majority group indicated that they would likely be compelled to follow suit if any of the organizations represented initiated anti-HBc testing programs. The report to be prepared will contain certain position papers summarizing the majority and minority opinions on this issue. It was clearly recognized by the study group that a positive finding of anti-HBc in an individual was not necessarily indicative of AIDS or the future development of the disease state. Rather, it was viewed as a possible mechanism of identifying high risk group members, a number of whom are positive for this serologic marker. It was the prevailing opinion of the study group that if testing programs for anti-HBc are employed, they should not be confined to the plasma donor population but should extend to whole blood donors as well."

Notwithstanding the majority opinion, some blood centres did introduce surrogate testing in the first half of 1984. Reference has already been made to two of them, the Peninsula Memorial Blood Bank and the American Red Cross blood bank at San Jose. About three other blood centres, all in San Francisco, also introduced anti-HBc testing during the first half of 1984. They included the Irwin Institute, directed by Dr Herbert Perkins. Dr Perkins had run a pilot anti-HBc HBc test program during 1983. But he then decided not to proceed with a full program; indeed, he expressed reservations about anti- HBc testing at the December 1983 FDA meeting. Also, at a stage which is not identified by the evidence, some blood banks in the New Orleans district of Louisiana introduced T4:T8 testing. The evidence does not reveal the number of banks that took this step, but I gather that they were only a few.
On 23 April 1984 a press conference was called in Washington DC by Mrs Margaret Heckler, Assistant Secretary of Health, to announce that the research team led by Dr Gallo had confirmed Dr Montagnier's identification of the agent responsible for AIDS. This was the virus now known as HIV. Mrs Heckler announced that pedigreed strains of the virus would be supplied to five pharmaceutical companies to enable them to develop a test which was specific to the identified virus. She promised that the test would be commercially available within six months.
In the meantime, blood bank operators had the continuing problem of how best to protect the blood supply from contamination. But there was no rush to adopt surrogate testing. So far as I can make out from the evidence, no more than about ten blood banks in the United States, out of some 2000, ever adopted surrogate testing. No blood banking or governmental organisation ever recommended the adoption of surrogate testing, of any kind.
The cause of surrogate testing suffered a set back by the publication of an article by Drs Toby Simon and Arthur Bankhurst, both of the University of New Mexico School of Medicine, entitled "A pilot study of surrogate tests to prevent transmission of acquired immune deficiency syndrome by transfusion". This article was accepted for publication in February 1984, although it was not actually published until the September/October issue of "Transfusion". The gist of the article is conveyed by its abstract:

"Because of reports that acquired immune deficiency syndrome (AIDS) might be transmissible by blood transfusion, we studied potential surrogate tests that could be used for screening donors. Male donors at one volunteer blood center and two plasma centers were screened for total lymphocyte count, OKT3, OKT4, OKT8, OKT11, LEU-7, LEU-M2, antibodies to hepatitis B core

(anti-HBc), cytomegalovirus (CMV), and herpes and circulating immune complexes. Total lymphocyte counts and the OKT11 were significantly lower in one plasma center. No significant differences were found for the other lymphocyte or monocyte tests. Low T4/T8 ratios, found in 20 percent of donors, did not correlate with other abnormalities. A small percentage (3.3%) of volunteer donors, 15.4 percent at one plasma center and 20.8 percent at a second plasma center, and 38.5 percent of the male homosexual donors were positive for anti-HBc (significant when comparing the male homosexuals to the volunteers at p=0.032). Positive CMV and herpes titers were similar in the groups. Circulating immune complex levels greater than two standard deviations above the mean were found in 20 percent of the volunteer donors, 7.7 percent at one plasma center and 8.3 percent at the second plasma center, and none in the male homosexual population. Pearson product moment correlations showed reasonably good agreement among the lymphocyte tests. However, the anti-HBc, CMV, and herpes antibodies and circulating immune complex levels did not correlate with any of the other tests. Surrogate tests for AIDS are nonspecific and unlikely to be helpful in screening blood donor units."

The conclusion expressed in the last sentence of the abstract has been criticised in this case. Dr John Ziegler, a senior lecturer in paediatrics at the University of New South Wales and a person with a long interest in immunology, said that he thought that the authors had "asked themselves the wrong question". He did not see any significance in the fact that there was little correlation between the results of the various tests. He thought that the relevant question was whether any one of those tests would provide reliable guidance as to the likelihood of HIV infection. If one would do so, it could hardly matter that the other tests provided no such assistance; that as between themselves they showed no consistent correlation. Dr Ziegler thought that the data revealed in the article actually supported the utility of the anti-HBc test. He referred to the finding that 38.5% of the tested male homosexuals were anti-HBc positive. I see the force of these criticisms. But, whatever the logic of the article's final conclusion, it was published in a respected, peer-reviewed journal which specialised in matters relating to blood transfusion. Apparently, it helped to entrench opposition to surrogate testing.
As is sometimes the way with the undertakings of politicians, the six months promise made by Mrs Heckler proved too optimistic. The new HIV test did not become commercially available, in the United States, until March 1985; although, in the meantime, some laboratories had been able to carry out limited testing, using cultured cells of the virus. When the commercial test became available, it was immediately widely adopted. The debate on the suitability of anti-HBc testing lapsed, except in the law courts.
As October 1984 is a critical month for the purpose of this case, before concluding this account of the position in the United States it is worth noting the then most recently published statistics as to the incidence of AIDS in that country, at least as revealed by the evidence. The 22 June issue of MMWR records that, as of 8 June 1984, 4,918 patients had been reported as meeting the CDC surveillance definition for AIDS. The number of new reports had increased in each quarter since the beginning of 1982. In the January-March quarter of 1984, the last full quarter available, the figure was almost 900. Of all reported patients, 45% were known to have died. More than 76% of the patients diagnosed before July 1982 were dead. Homosexual and bisexual men accounted for 72% of all patients, intravenous drug users a further 17%. Fifty two adults (about 1% of all patients) had been transfused with blood or blood products within two years of the illness onset and had no other known risk factor`for AIDS; of them, 27 had died.
By way of footnote to these figures, and illustrating the point I made at the outset of these reasons about events since 1984, I add that - according to an article by Dr Susan Leitman and others, published in NEJM on October 5, 1989, and to which I will return in another context - in the further four years to June 1988 the total number of reported American cases multiplied sixteen times to 79,823, of which about 3% (2144) were blood transfusion-associated cases.
AIDS in Australia
The evidence shows that the major American medical journals circulated widely in Australia. I have no doubt that practitioners in relevant specialist areas, including immunology and blood banking practice, were aware of the reports in the American literature. But, so far as the evidence reveals, there was no article on AIDS in any Australian medical journal until 11 June, 1983. On that day "The Medical Journal of Australia" published five articles. One article, written by Professor Ronald Penny of the University of New South Wales and St Vincents Hospital, Sydney, and others, reported the illness of a 27 year old American homosexual man who was treated in St Vincents Hospital for AIDS-like symptoms in late 1982. The authors indicated their belief "that this patient represents the first Australian case of a new disease which has become known as the acquired immune deficiency syndrome (AIDS)", which they went on to describe in some detail.
Two articles concerned the prodromal form of AIDS (lymphadenopathy). One was written by six members of the Department of Clinical Immunology at The Royal Prince Alfred Hospital, Sydney, including Dr Paul Gatenby, a witness in this case. They reported case studies "of two homosexual men whose symptoms may represent early examples of prodromal AIDS in Australia". Only one of the patients was reported as having visited the United States. The other dealt with two prodromal cases treated at Concord Hospital. A further article, by Dr David Cooper of St Vincents Hospital contained a report of an AIDS symposium at the New York University Medical Center which he had attended during the previous March.
These articles were introduced by a leading article written by Dr Mutton and Professor Gust, of Fairfield Hospital. They referred to the "growing feeling that a novel agent is involved" and said that "transmission via blood and blood products seems likely". Their article concluded:

"Homosexual persons, or others seeking advice about personal risk, should be advised to restrict their number of sexual contacts and avoid recreational drug exposure. The predictive value of screening for T-cell subset abnormalities and other possible markers, such as serum thymosin a, and serum b, microglobulin levels, is unclear."

Reading these contributions to "The Medical Journal of Australia", it seems to me that their combined effect was to supply readers with a comprehensive understanding of the aetiology and epidemiology of the disease, insofar as these were known, together with an understanding of its extent and morbidity within the United States. But none of the articles made suggestions for preventative measures, except for the suggestions about homosexuals restricting sexual activities and the avoidance of recreational drug use. However, some thought was being given to these matters, at least in connection with blood transfusion. Even before the publication of the 11 June articles, but after he learned of Professor Penny's case, Dr Gordon Archer, the Director of the Blood Transfusion Service ("BTS") of the NSW Division, made a public statement - apparently in early May 1983 - requesting homosexual men not to donate blood. The evidence does not reveal the terms of this statement, but whatever they were, the statement was given prominence in the media. It brought upon Dr Archer the wrath of some people within Sydney's homosexual community. The blood bank in Clarence Street, Sydney was picketed for a time. A pamphlet entitled "Ban the Bigots Not Blood" was distributed. This pamphlet described Dr Archer's move as "alarmist and irresponsible". It quoted Dr Bove, in his capacity as chairman of the American Association of Blood Banks ("AABB"), as saying that "the evidence is that ordinary blood transfusions are not transmitting AIDS". The burden of the pamphlet appears from what was said under the heading "What is Wrong with Dr Archer's Proposed Banning of Gay Donors":

"First of all, it is the blood and not the donors that needs to be screened. In the USA it has been discovered that two tests - Hepatitis B and SBA and SGPT - when taken together, show a hundred per cent corellation with AIDS risk. The tests cannot identify if some-one actually has AIDS, but they do identify accurately all at risk blood. The blood that has been so identified could then be used for research purposes. By discouraging donors and not screening the blood, we lose valuable opportunities to discover more about AIDS. Secondly, homosexuality as such is not a risk factor. The question of whether some-one is at high risk with AIDS can only be determined on the basis of each individuals medical history and environment. The best way of ensuring this sort of screening is to provide accurate information at the blood bank for the donors themselves to assess.

Finally, a media campaign is likely to be counter productive for effective screening. Many homosexual men could feel they must now give blood, irregardless of their particular risk factors, to prove to their friends and colleagues that they are not gay. The fact of the matter is that if Dr Archer is concerned about the risks of homosexual men contracting AIDS he should take action on the single greatest stumbling block to an effective health policy - the continued criminalisation of gay men in NSW."

In his evidence in this case, Dr Archer was taken to this pamphlet. He said that he read it at the time. He telephoned Dr Bove who said that he "had no idea what SBA means". Dr Archer added: "and I have not been able to find out anybody else who has. SGPT is a liver enzyme test" now called ALT "and hepatitis, of course would refer to hepatitis B markers. He (Dr Bove) did not know how that got into the pamphlet though ... and it was not from his mouth that these suggestions had come". Dr Archer added that Dr Bove told him that AABB was not recommending the tests.
To go ahead for a moment, the evidence suggests that Dr Archer made significant efforts to persuade members of the homosexual community to accept his request that they not donate blood. He established contact with a number of homosexual organisations, supplying them with information for their publications. He attended a public meeting at Paddington Town Hall on 15 August 1983 organised by some prominent members of the homosexual community. Some hundreds of people were present. The speakers included Professor David Penington who was then Chairman of the National Health and Medical Research Council ("NHMRC") Working Party on AIDS, Chairman of the National Blood Transfusion Committee of the Australian Red Cross and also Dean of the Faculty of Medicine in the University of Melbourne. Professor Penington spoke about the risk of transmitting the infection by blood donations. Dr Cooper pointed out the similarities between Sydney and San Francisco. I gather that the meeting went well and that Dr Archer had cause to believe that his request was being understood.
On 9 June 1983, Dr Archer attended a meeting convened by the New South Wales Department of Health to discuss the scientific aspects of AIDS. Also present were representatives of many of Sydney's leading hospitals, including Professor Penny of St Vincents and Dr Gatenby of Royal Prince Alfred. There was discussion about the known cases, apparently those which were to be reported in "The Medical Journal of Australia" two days later. The minutes of the meeting record Dr Archer as having confirmed "that blood bank has acted on Commonwealth's advice and is not taking blood from male homosexuals irrespective of whether they have had 'multiple partners'. Blood Bank's message is to be circulated to all hospitals". The minutes of the meeting also contained the note:

"There is no single surveillance nor any single diagnostic test for A.I.D.S. but the regular immune status tests are available at all immunology units and haematology and virology units at the major centres are adequately equipped for the work they may have to do on A.I.D.S. specimens."

The minutes contain no reference to the possibility of surrogate screening for AIDS.
However, surrogate testing was the subject of lengthy discussion at an AIDS symposium in Perth on 23 July 1983. That symposium was attended by many Western Australian medical scientists and also by some visitors from the eastern States, including Professor Penny and Professor Penington. One of the local scientists present was Dr M. Whisson, the Director of the Western Australian BTS.
The symposium reviewed at some length the available information about the incidence of AIDS. Although Dr Montagnier had yet to announce his identification of the AIDS virus, Dr Penington made this statement:

"The evidence that AIDS is transmitted by blood and blood products is, in my view, beyond reasonable question. The haemophiliacs in the United States have been closely followed medically over many years. Although they have a variety of complications from the haemophiliac lifestyle, including the intermittent administration of concentrate, cases of rapidly progressive immune deficiency, associated with life-threatening infective illnesses, are new. I believe there are now fourteen cases reported, all of whom received concentrate rather than cryoprecipitate (the concentrate originating in either the New York or the San Francisco area). These have occurred over a relatively short period and when one looks at that evidence one cannot ignore that the concentrates do transmit an agent that causes a disease which leads to high risk of death from opportunist infection, and that this is new."

Professor Penington made the observation, as a haemotologist, that "where one is administering products to large groups in the population, one has a responsibility to make a decision as to the probability of risk and an obligation to keep risk to an absolute minimum based on such evidence that is available, whether good or indifferent".

There was discussion about the extent of the problem, Dr Whisson giving some calculations to the effect that there could only be "about 0.025 donors with AIDS per year - or one donation in 50 years in Australia". His calculations were made by reference to the United States. Dr Whisson assumed that, in the United States, there were only 800 AIDS affected people who were well enough to survive the usual blood bank inquiries as to recent health. He applied to that figure the usual ratio of donors to population (5%), giving 40 AIDS affected potential donors. He assumed that 90% of those donors would respond to the request for high risk people not to donate, so that only four AIDS affected people would actually donate blood. He then assumed that each would donate blood once per year, so that there would be four affected donations each year of which three would be used. Dr Whisson then applied the result to Australia, on a population basis; but, in doing so, he made a ten times error. On his own figures he should have concluded that there would be one infected donation in Australia each five years. Nobody at the meeting questioned his assumptions or pointed out the mathematical error.
In fairness, Dr Whisson did recognise the significance of even one infected donation. He said that, having regard to the practice of pooling donations, "one donation in a 2,000 donor pool can make the whole lot infective".
Professor Penington accepted the need to keep the problem in perspective but reiterated his opinion about blood transmissibility. He added:

"We would be irresponsible if we did not take sensible precautions to minimise the risk of transmission of the disease into this country, and to minimise the risk of spread of disease from the high risk groups (the intravenous drug users and homosexuals) to others in the community. We have to make decisions on rather more nebulous criteria than scientific proof."

The discussion turned to preventative action. Dr Whisson mentioned some problems which he had encountered after the Western Australian BTS requested that active homosexuals with multiple partners not donate blood. He said that the request had led some homosexuals to attend in order to demonstrate their normality. Others had attended in the belief that tests will be done by the BTS, so if "they do not receive a letter saying something is wrong they presume that they do not have AIDS". He said that there were aggressive donors whose attitude was: "We will donate come what may" or "No one is going to tell us that we cannot be donors"; cf. the statement in the "Ban the Bigots" pamphlet about "the stumbling block" of "continued criminalisation of gay men in New South Wales".

Dr John Dwyer, Professor of Medicine and Head of the School of Medicine at the University of New South Wales, was also called on behalf of the applicant. Professor Dwyer is an immunologist. Between the years 1978 and 1988 he was Chief of the Clinical Immunology Section of the Departments of Medicine and Paediatrics at the Yale University School of Medicine. Simultaneously, he held positions within the university, first as an Associate Professor and subsequently as Professor of Medicine and Professor of Paediatrics. Professor Dwyer returned to Australia in 1985 to take up his present position. He has since served on a number of committees dealing with AIDS.
There is no doubt that Professor Dwyer is well-informed about the nature and dimensions of the current AIDS problem in Australia. However, in addressing the question whether surrogate testing ought to have been introduced in Australia before August 1984 - and, if so, when - he suffers the significant disadvantage that he was then living outside Australia. Living in America, he followed the American debate about surrogate testing. In his affidavit he said that, at the time, it was his belief "that there was potential for this test to be useful" as a"reductionist approach to this problem". In cross-examination Professor Dwyer was challenged on this answer, reference being made to some evidence which he had recently given in Melbourne, during the course of which he said that none of the suggested surrogate markers was reliable and that he was concerned that the use of these might lead to some false sense of security. Professor Dwyer explained that, in the Melbourne case, he was speaking about a time earlier than mid-1984. During the course of this explanation, Professor Dwyer made it clear that his support for surrogate testing in this country was related to the circumstances, as he understood them, that by July 1984 there had been several blood transfusion HIV cases, the first in about January 1984, and that the Australian Red Cross wished to take every means possible to minimise the spread of the disease. Of course, this understanding of the facts was erroneous; July 1984 being the date of the very first Australian case. However, Professor Dwyer's indication of his reasoning shows that his opinion provides no support for the proposition that surrogate testing should have been introduced before the first reported transfusion case.
The remaining applicant's witness to deal with surrogate testing was, of course, Professor Engleman. Professor Engleman claimed no knowledge of the Australian scene in 1983-1984 and he was not asked to comment upon the date when it would have been reasonable for Australian blood bankers to introduce surrogate testing. As I have already recounted, Professor Engleman adopted T4:T8 surrogate testing at Stanford in the first half of 1983 and thereafter urged other blood banks to use anti-HBc. But he did not suggest that a blood bank would be remiss in failing immediately to adopt his precept. During the course of cross-examination, he was asked whether he thought that it was a violation of reasonable and prudent medical conduct for blood banks in the United States to fail after January 1984 to introduce surrogate testing. He responded that this depended on location "but certainly in high risk areas I would have felt it was a violation". His evidence continued:

Q: "Not universally?"

A: "No, and I am sorry for being fuzzy on this point but I feel fuzzy on it. I feel that mid 84 was really the cut-off for the entire country for surrogate testing." Q: "For high risk parts of the country?" A: "No, for all parts of the country by mid 84. For high risk areas certainly by the beginning of 84." Q: "So in the four or five months between February 84 and June of 84 do you say that there was a change in medical information such that you would regard it as unreasonable and imprudent of any blood bank not to have a surrogate test, is that right?" A: "Yes, although it is not merely the change of information. It is a reflection of how much time has passed during which information was available and increasing amounts of information became available."

Asked about the particular information which had become available, Professor Engleman referred to the NEJM article of January 1984 dealing with AIDS and haemophilia. He commented that, by the beginning of 1984, CDC had recognised approximately 50 cases of transfusion transmitted AIDS. His evidence went on:

Q: "What I am really asking you is this: what is it that happened in 1984, or December 83 or earlier, that you say required them, in effect, to see the light?" A: "In my view it was a combination of factors. There was an acknowledgement of the increasing frequency, geometrically increasing frequency of transfusion transmitted AIDS cases that were paralleling the growth in the epidemic as a whole. There was knowledge of an ever lengthening period of latency between the time of exposure and the time of disease manifestations. There was knowledge, at least amongst blood bankers, of surrogate testing as an issue and the availability of the Hepatitis B core antibody test for example. And there was knowledge that the disease AIDS was a terminal illness from which there was no defined agent, even thought everyone felt - I should say almost everyone felt that there was an infectious agent, a new infectious agent. It had not been identified, there was no treatment. So I think those are the issues on which I argue that there was a transition, or should have been." Q: "When do you say that those different factors had matured sufficiently to expect your colleagues to have responded to them?"

A: "Approximately the middle of 1984."

It is not easy to fit New South Wales, and in particular Sydney, into Professor Engleman's range of risk areas. In 1983-1984 Sydney had a substantial homosexual and intravenous drug-user population. No doubt Sydney had, and has, characteristics similar to those of San Francisco. But in 1983-1984 Sydney had nothing like the number of reported AIDS cases which had occurred in San Francisco. If a list of reported cases per city had been compiled, it seems certain that Sydney would have ranked below a large number of American cities. I think that it would not be reasonable to treat Sydney as falling within Professor Engleman's "high risk" category. Moreover, as the above extracts from his evidence make clear, Professor Engleman's reasoning was greatly influenced by his knowledge of the CDC figures on reported transfusion and haemophilia-related AIDS cases. There was no such reported case in Australia until July 1984. Accordingly, I do not think that Professor Engleman's evidence supports the proposition that the failure of the New South Wales BTS to introduce surrogate testing before the Lokar case was a violation of prudent medical practice.
The claim that the first and second respondents ought to have decided to adopt anti-HBc surrogate testing earlier than August 1984 suffers from the handicap that it is opposed to the practice which predominated in the United States, the country with the greatest experience of AIDS cases. That handicap is formidable; but, as I have indicated, I would not be prepared to regard it as decisive. If I felt that, upon the evidence available to the Court, the only prudent course for persons in the position of the first and second respondents - in the light of their then knowledge - was to introduce anti-HBc, I would uphold the claim of breach of duty, whatever the American practice. But such a course would involve the Court in making the judgment, without any supporting expert evidence, that a prudent blood banker should have determined that it was better to accept the loss of 5% of the blood supply rather than the mere risk of HIV contamination of the blood supply. Particularly in the absence of evidence as to the consequences of losing 5% of the blood supply, I cannot make that judgment.
So far as the third respondent is concerned, it seems to me that it is an even stronger position than the first and second respondents. The Royal Prince Alfred Hospital had no source of blood other than the New South Wales BTS. The New South Wales BTS was an organisation of high reputation with which the hospital had dealt for many years. It had a specialist interest in the maintenance of blood quality. I think that the hospital was entitled to rely upon the judgment of the BTS as to the tests appropriate to be applied to the blood which it supplied.
Negligence: delay in implementing the surrogate testing decision

In the alternative, counsel for the applicant argue that, even if it was not imprudent for the respondents to fail to make an earlier decision about surrogate testing, they were unduly tardy about implementing their decision. They point out that the full testing program, for Sydney donations, was in place by 25 October 1984, only three weeks after the taking of D9's donation. Counsel say that, with greater speed of implementation, that donation would have been tested, found anti-HBc positive and discarded. The last step in this argument is challenged by counsel for the respondents. They point out that the evidence does not establish, with any degree of certainty, whether or not D9 would have tested anti- HBc positive on 3 October 1984.

I accept that there is no certainty as to whether D9 was anti-HBc positive on 3 October 1984. He was anti-HBc positive at the time of his next donation, on 21 March 1985. But he could have become HBV infected after 3 October 1984 or, being infected on that day, have not provided a positive result, either to the hepatitis B surface antigen test which was then made, in accordance with the usual routine, or to any anti- HBc test which might have been put into place.

However, it is now known that the donation given by D9 on 21 September 1983 was HIV positive. As one of the medical witnesses observed, that positivity provides a clue to his lifestyle at that time; the probability being that he was then either a homosexual, an intravenous drug user or a sexual partner of an intravenous drug user. Hepatitis B is common amongst all these groups of people. It is common ground that hepatitis B core antibodies remain within the blood stream for many years after infection. So the hepatitis B antibodies detected in March 1985 could be the result of an infection in 1983 or earlier. Purely upon the basis of opportunities for infection, it is more likely than not that D9 was anti-HBc positive on 3 October 1984.

However, I am unable to accept the earlier propositions in the applicant's alternative argument. I have already detailed the steps taken to implement Dr Archer's decision to introduce anti-HBc testing. I do not think that either he or the NSW Division may reasonably be criticised for delay. Implementation of the decision involved the selection and importation of new equipment and the recruitment and training of three additional technicians. The contemporaneous documents show that a sense of urgency pervaded the procurement of the equipment and there is no reason to think that it was otherwise in relation to the new staff. The period which elapsed from the date of Dr Archer's return from Munich on 31 July 1984, when he set about making his inquiries as to current United States practice, until there was full testing of all Clarence Street donations was about 12 weeks. Bearing in mind all that had to be done, I do not think that this period exceeded what was reasonable.

Finally, counsel for the applicant point out that limited testing was taking place during the period of nine days which elapsed between the taking of D9's donation and the supply of part of that donation, in the form of fresh frozen plasma, to the applicant. The plasma was frozen shortly after the blood was taken from D9. Nonetheless, according to the evidence, it would have been possible to test its anti-HBc positivity, after first thawing a small portion of it. Counsel say that this should have been done. When testing commenced, the BTS should have started with the stock in store. Had it done so, counsel argue, D9's donation would have been tested and discarded.

I do not think that this is a reasonable criticism. When regular anti-HBc testing began on 5 October the BTS technical officers at Clarence Street could handle only about 200 tests per day. They were inexperienced. The third new officer had yet to commence. The Clarence Street blood bank was taking about 400 donations each day. So at that stage the testers were not even coping with the new donations. It took about three weeks before they were able to do so. In the meantime, unless substantial quantities of blood were to be held unused, some untested blood would have to be supplied to hospitals. If the officers had tested the blood in store, a greater proportion of new blood would have been left untested. This would have made no sense; especially in the light of Dr Archer's evidence that the testing of already frozen plasma is a much more complicated and time-consuming process than the testing of a new donation in conjunction with its other routine tests. The desirable object was to test as many donations as possible each day, recognising that some donations must, for a time, go untested. Moreover, it was important to guard against errors. Dr Archer said that to take samples out of order "would have caused utmost confusion. If you do not have samples in serial order, you get hopeless confusion for identification". This evidence was given with some feeling. It makes sense and I accept it unhesitatingly.
Conclusion
My findings against the applicant, in relation to each of the bases of liability argued on his behalf, require me to dismiss his Application. There being no legal reason to the contrary, the applicant must be ordered to pay the respondents' costs. The question whether that order is enforced depends on matters outside my control.
In one sense, it is a cause of satisfaction to reach the conclusion that institutions with the respondents' reputations and history of service to the community have not been proved derelict in their duty towards the applicant. In another sense, the result gives me no satisfaction. During their addresses, counsel for each of the respondents expressed the concern of their client about the future of the applicant. I am sure that, in so doing, they spoke also for themselves and their instructing solicitors. Nobody could have sat through this case without developing a deep sympathy for the applicant and his wife and an admiration for the stoical manner in which they have borne their affliction. No amount of money could compensate them for the injury they have suffered, but a monetary award would have made it easier for them to cope with the problems that lie ahead. However, I must decide the case according to law, and the evidence establishes no basis upon which the respondents may be required to pay damages.
Nonetheless, I cannot forebear the comment that this applicant, and any other people who are in a like position, have a strong moral claim upon the community for some financial assistance in coping with their illnesses. Upon the probabilities, the earlier introduction of anti-HBc surrogate testing would have led to the discarding of the donation which caused the applicant to become HIV infected. The only substantial argument against the earlier introduction of anti-HBc testing is that it would have led to the wasting of something like 5% of all donations, most of which were in fact suitable for use. Although surrogate testing was not considered before August 1984, I must dismiss the claim because I am not satisfied that, had it been considered, a reasonable person in the position of the respondents would have decided to introduce anti-HBc testing at an earlier date. This is not because I doubt the foreseeability of HIV infection from a blood transfusion or that anti-HBc surrogate testing had a useful role to play in reducing the risk of such infection. The reason for my conclusion is the possibly serious effect on the blood supply. In the absence of that possibility, I would certainly hold the applicant entitled to recover damages.
But this is where the moral claim arises: to take into account the effect upon the blood supply is to say that a person in the position of the first and second respondents was entitled to give priority to the interests of all blood users - and everyone in the community is a potential blood user - over the interests of the relatively small number of individuals who might receive infected blood. To so say is to make the present applicant bear the burden of protecting the wider public interest. In some other areas of activity, in which individuals are sacrificed for the wider public good, the community recognises an obligation to provide some recompense; for example, under war veterans' legislation. Perhaps the same attitude ought to be taken towards those people who contracted AIDS as a result of a blood transfusion or haemophilia treatment. I do not have in mind any extravagant award of money, but something to make up for the income which they have lost or will lose - after taking into account any social service entitlements - and their out-of-pocket expenses. I am aware that a fund has already been established but its adequacy is a matter of controversy. I say nothing about that matter. I merely express the hope that the extent of the benefits available to people in the position of the applicant will be reviewed in the light of these reasons. Apart from anything else, agreement upon a sufficient level of assistance might eliminate the need to determine most of the cases which remain pending in this Court and in other courts; whose litigation will divert into legal costs many millions of dollars which might better be spent on the victims of the problem.
The formal order of the Court will be that the Application be dismissed with costs.

[1991] FCA 20

08 FEBRUARY 1991