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Macedone Christie Willis -
Letter to Federal Parliamentarians
KW:951015 3 November, 1997

Dear Sir/Madam,


As you are aware, we act for a number of recipients of human pituitary hormones who have commenced legal proceedings against the Commonwealth of Australia (the `Commonwealth'), the Commonwealth Serum Laboratory Ltd ( the `CSL') and various medical practitioners.

A number of our clients are constituents of your electorate. Our clients, in addition to over 2000 other human pituitary hormone recipients Australia-wide, are at risk of developing a fatal degenerative neurological disease, Creutzfeldt-Jakob Disease (CJD) as a result of the hormone treatment they received. The human pituitary hormones were manufactured by the CSL Commission from 1966 until 1985 and were distributed under a program administered by the then Commonwealth Department of Health, now the Commonwealth Department of Health and Family Services ( the `Department'). The Australian Human Pituitary Hormone Program (the `AHPHP") was suspended in 1985 following reports of the deaths of recipients overseas from CJD. Most recipients were not advised of the fatal complications associated with the hormone treatment and their significantly increased risk of developing CJD until some seven years later.

It is known that five recipients in Australia have died from CJD in recent years as a result of receiving injections of CSL's hormones which were contaminated with the infective agent of CJD. A sixth recipient has recently developed symptoms of the disease almost thirty years after the treatment was administered and is expected to die shortly.

The recent Report of the Senate Community Affairs References Committee (the `Committee') again drew the public's attention to this most horrific chapter in Australian medical practice. Prompted by concerns that a recent offer of settlement made by the Commonwealth was not fair or adequate, the Committee considered a number of issues relevant to the Department's and CSL's role in the AHPHP. These issues included the actions of the Department in the conduct of the litigation and whether the safety of the public was adequately protected by inter alia the CSL, the Department and/or other Commonwealth departments and agencies.

The Report of the Committee is the second damming Report of the Department's role in the AHPHP which has emerged in recent years and has revealed again for general public scrutiny the mismanagement, major flaws and ineptitude which dominated the program.

In 1993 the then Minister of Health, Senator Graham Richardson announced an Independent Inquiry, the Inquiry into the use of Pituitary Derived Hormones in Australia and Creutzfeldt-Jakob Disease chaired by Associate-Professor Margaret Allars (the `Allars Inquiry'), after deaths of a number of Australian recipients emerged. In 1994, the Report of this Inquiry (the `Allars Inquiry'), was tabled in Federal Parliament. Like the Committee's recent Inquiry, the Allars Inquiry made a number of damning findings.

We are currently awaiting a formal response from the Commonwealth Minister of Health and Family Services to the recommendations made by the Committee. It is hoped that the Minister will implement the recommendations contained in the Committee's Report and compensate our clients and other recipients who satisfy certain criteria.

If the recommendations are not implemented, those recipients who continue with the litigation to seek compensation for their injuries would be placed in the unenviable position of having to attempt to, as best they can, match the extensive resources available to the Commonwealth in defending the litigation. It remains to be seen whether legal aid will be forthcoming. In light of the recent budgetary reductions in legal aid and the fact that a Victorian firm was unable to obtain legal aid for their test case, we are not confident that such assistance will be forthcoming. The Victorian firm was unable to continue with the test case when legal aid was refused by the Commonwealth Attorney-General's Department. The decision not grant legal aid was made by the Commonwealth.

The litigation will be expensive, time consuming and complex. One can understand the genuine confusion shared by many recipients as they contemplate why it is even necessary to proceed through the Courts when two independent bodies have already condemned the program and the Department's and CSL's role in facilitating the debacle. In many respects we agree that it would be a tremendous waste of public resources to have a Court consider the issues again. However, if the Minister refuses to compensate injured recipients, litigation is the only alternative. The cost of litigation could be better served in compensating the recipients.

A summary of the more important findings of the Allars Inquiry and the Committee's Inquiry are enclosed. These findings, in addition to the material contained in the documents discovered to our clients by the Commonwealth and CSL during the course of the litigation, raise serious concerns about the acts and omissions of the Department and CSL in the past.

In short, the AHPHP was unlawful, ethical requirements were not observed and the authorities did not respond to the possibility of viral and slow viral contamination of the product. Arguably this tragic chapter in Australian medical history could of, and should have been avoided.

As a result of conflicting evidence given to the Senate Inquiry (including debate as to whether or not hormone contaminated with hepatitis virus was knowingly distributed by CSL for administration to recipients) the Committee recommended that Associate Professor Allars, or another suitably qualified person, be invited to review the additional material which had been forthcoming so that the findings of the Allars Inquiry could be reviewed and expanded upon.

The Committee heard evidence from a number of scientists, some of whom have perused the files and documents of the CSL and the Department. As noted in the Committee's Report, one scientist, a virologist, gave evidence to the Committee that:

"In relation to the CJD and hepatitis contamination of pituitary hormones, the failure of both CSL and HPAC to subject the gel chromatography technique to a very detailed critical analysis in relation to the possibility of contamination with viruses as a general problem, was, in my view, a major contributor to the disaster"

This evidence addressed the central argument of the Commonwealth which has been advanced to date, that is, the authorities believed at the time that the processing methods used by CSL would eliminate virus.

However, as this virologist properly points out, the ability of the processing to eliminate virus from the final product was never tested.

A CSL officer was asked, during the last day of public hearings, whether they were aware of the minutes of a meeting of the Fractionation Subcommittee (the `FSC') in 1970 where the FSC conceded that there was no guarantee that virus would be eliminated during processing. It would appear that the discussion at this meeting undermines the Commonwealth's and CSL's argument that the processing method would eliminate virus. Curiously, the relevant CSL officer advised the Committee he was "not aware" of those minutes. Furthermore, the same officer also advised that he was "not aware" that the FSC also conceded that because exclusion criteria had not been complied with in the past, past batches of the hormones may have been contaminated with virus. Further evidence was given by the Department that there was no action taken to monitor the health of recipients to determine whether viral diseases were being transmitted to recipients via the hormone treatment.

It is clear that the Allars Inquiry was given, on a number of occasions, false and misleading information about material matters and that the Inquiry may not have been given all relevant information and documentation. Significantly, the Committee noted:

" ... the Committee considers that some of the information which came to light during the [Committee's] inquiry does raise serious concerns and warrants a further review. It also appears that some of this information was not available to the Allars Inquiry".

[emphasis supplied]

We are confident that overwhelming evidence can be presented to the Court that because of significant production and quality control difficulties (quite apart from the question of viral and slow viral infection), the hormones were not fit for use in humans and should never have been distributed. For example, one scientist, a former NBSL officer, gave evidence before the Committee that CSL's best hPG was 99.6% impure and that:

"It was a shocking product. I cannot believe that this could have been marketed".

[emphasis supplied]

Not only was it marketed, it was injected into human beings, who were used as human guinea pigs. This is most reprehensible conduct.

We are more than convinced that negligence can be proved in a Court of law, on the balance of probabilities, against the Commonwealth, the CSL and the medical practitioners who were responsible for the treatment our clients received. We are also confident that we can prove that our clients have suffered psychiatric injury as a result of their negligence.

In denying liability, the Commonwealth and CSL have relied upon an overly narrow interpretation of the common law as it relates to "nervous shock" claims. It is the opinion of this firm, and that of our two Counsel, one of whom is a Senior Counsel, that the common law accommodates these claims and provides for compensation to recipients.

Significantly, a number of other firms who have, or do act for recipients, in addition to their Counsel, are of the same view. The Commonwealth's and CSL's narrow interpretation of the law is even more curious when one considers that all, if not most, of the legal firms involved, and their Counsel, act for their recipient-clients on a contingency basis - an indication of ours and their belief that the recipients will be successful at trial.

Moreover, in 1995 the Commonwealth sought to strike out the proceedings commenced by a recipient in the Supreme Court of Victoria claiming there was no cause of action disclosed. His Honour Justice Harper delivered a judgment confirming that the common law could accommodate these claims and dismissed the Commonwealth's application.

One must also consider the judgment of the High Court in the United Kingdom last year, where it was found that the Defendants were negligent for the deaths of hGH recipients from CJD where recipients were treated after July, 1977. The Court's decision in this respect was based on the availability of knowledge on the transmissibility of CJD. That very knowledge was also available in Australia in widely read and prominent medical and scientific journals. We believe that while the Court's judgment is conservative it is nevertheless reassuring.

It is our opinion that there are no significant legal or evidentiary obstacles preventing injured recipients from obtaining compensation for their injuries from the Commonwealth and CSL.

When the Committee's unanimous Report was tabled in the Senate, Senator Brian Harradine (a Committee member) commented that:

"Our examination of the whole CJD episode provided a window into lax processes and cover-ups by those responsible for regulating human experimentation and by those whose grave duty it is to ensure the highest standards in the regulation and manufacture of biological products ... Women seeking help for infertility , and men and women of short stature were essentially guinea pigs in an unlawful experiment ... CSL did not meet the requirements of the Australian regulatory authorities ...There was enough information in 1966 to indicate that the program should not have been allowed to proceed"

[emphasis supplied]

The comments of the current Treasurer, the Hon. Mr. Peter Costello in 1993, are also significant and reflect the decision the Commonwealth ought to have made years ago. They also reflect the decision the Commonwealth ought to make now in light of the recent Report of the Committee:

" ... The Commonwealth can either spend its money on lawyers or on the victims. It will not necessarily be cheaper to spend the money on the lawyers; the Commonwealth will be paying which ever way it goes. As a matter of justice, it would be far more helpful to those who have suffered if the Commonwealth said that on this occasion its beneficence will be directed towards the victims, the families that have suffered the death and loss of a loved one, rather than the legal profession defending the claims ..." [emphasis supplied]
Had the Department followed this advice in 1993 much anguish and anxiety in the recipient community would have been avoided. Ironically, many of the psychiatric injuries suffered by recipients could have been minimised or avoided instead of being aggravated. More importantly, significant public monies could have been better utilised compensating recipients instead of funding the Commonwealth's and CSL's vigorous defence of the proceedings. As the Report of the Committee indicates, the Commonwealth has not been the `model litigant' it ought to be.

When one considers the comments of the then Chief Medical Officer of the Department in 1994, one wonders why the proceedings are being defended by the Commonwealth and CSL at all. In a current affairs program, Dr. Tony Adams made the following comments about the AHPHP and in doing so, made certain admissions:

"In many instances in the development of new therapies, people are used as guinea pigs, and unfortunately guinea pigs do not have a chance to give their fully informed consent as to what is being done to them...

... They were overenthusiastic, so some of the guidelines that were in place were either ignored or fudged

[in answer to the question "So patient's welfare was sacrificed?"] Unfortunately yes ...

Here was a situation that should have been corrected earlier than it was and people concerned both in Government and in the Committees who were handing out the hormones were derelict in their duty in not stopping it sooner"

[emphasis supplied]

The litigation commenced on behalf of our clients will continue if our clients are unable to obtain compensation for their injuries pursuant to the Committee's recommendations. The litigation will be extremely costly for all parties involved, It will be lengthy and time consuming and significantly demanding on the recipients who will continue. As the Committee noted:

"No doubt the costs and pressures of litigation have the potential to add greatly to the psychiatric stresses on recipients".

[emphasis supplied]

Ultimately it will be the tax payer who will bear the heavy financial burden if the litigation proceeds. In the event that our clients are unsuccessful, it is likely that the Commonwealth and the other Defendants will not be able to recover their legal costs pursuant to a costs order. Our clients are ordinary citizens. Many of our clients have few, if any, assets. In the event that our clients are successful, it will be the taxpayer who ultimately meets the tremendous legal costs which will be incurred by this, and possibly other legal firms.

There is no doubt that there will be further deaths of recipients in this country in the future. Over 100 deaths of recipients from CJD have been recorded world-wide. The remaining recipients now live with the constant reminder that they may have received contaminated injections and the knowledge of the possibility that they may develop and die from CJD at an unknown date in the future. There is currently no diagnostic tool available to determine those recipients who have received contaminated hormones and who will develop the disease. There is no cure. There is, at present, no apologies forthcoming from those who are responsible and certainly no acknowledgment that the authorities may have been derelict in their duty. There is currently no compensation for those who have suffered injury as a result of the negligence of others and those responsible are yet to be held accountable.

In the event that the Commonwealth compensates injured recipients pursuant to the Committee's recommendations, no binding precedent will be created. The argument of the Commonwealth that they can not compensate recipients as it would open a "flood gate" of claims against the Commonwealth is no basis for refusing to compensate recipients in these circumstances. When gross negligence and consequential injury has occurred, it is highly inappropriate for the Commonwealth to rely on groundless emotive rhetoric to deny compensation.

As the Federal Member of Hughes, we respectfully request that representations be made to the Minister of Health and Family Services on behalf of your constituents without delay. It is time the Department and CSL addressed the gross errors of the past by implementing the Committee's recommendations immediately, whether it be for moral or legal considerations

Yours faithfully,