SETTLEMENT

DIRECTIONS HEARING

ADELAIDE MAGISTRATES' COURT

MINOR CIVIL ACTION

Plaintiffs' File

13th May, '98

SETTLEMENT.

On the 12th day of November, '97 the following Personal Injury claim was settled in the Victorian Supreme Court for the Plaintiff.
It excludes the health care costs.

BANSEMER,MARGARET ANNE-AND-
C.S.L. LIMITED and COMMONWEALTH OF AUSTRALIA1.

Peter Bansemer acts for the Plaintiff, Margaret Bansemer.

Disease indicative of acquired Creukesfeldt-Jakob Disease(CJD)2.

***
ACCESS TO THE TRUST FUND

NEGLIGENCE.

This action relates to the care component to be provided by the Commonwealth Department of Health through its Trust Fund4a. The Commonwealth of Australia disallowed negotiations by the Plaintiff to settle for health care costs in the preliminary settlement negotiations. All care costs are to be reimbursed from the Trust Fund.

The Defendants can not deny that the Plaintiff's demise, irrespective of the diagnosis, is not a consequence of treatment with contaminated pituitary hormones. CJD is only one known possibility.

The Commonwealth Department Of Health acting for the Commonwealth of Australia and CSL Ltd claim that negligence has not been admitted nor proven and as such have denied the Plaintiff further access to the Trust Fund4 established by the Commonwealth as of the 31st March, 1998 pending a definitive diagnosis5. Access to the Trust Fund is at the discretion of the Commonwealth Department of Health.

The Defendants, claiming not to be negligent, seek to time limit access to the Trust Fund4b in all future claims.

A definitive diagnosis is not possible6 ,2 as this document clearly indicates.

Res Ipsa Loquitor7 (the facts speak for themselves)

The facts detailed below clearly demonstrate gross negligence by the Defendants.

Refer: Janet Kambet & C. et al., Appellants v St Francis Hospital
Prior v Kanna et al., 1987.

SUMMARY OF DOCUMENT.

1. The Commonwealth of Australia has exposed the Plaintiff to an exotic disease, Kuru8b, that was known to present in New Guinea by the issuance of a license9 for CSL to import pituitary glands from New Guinea. The Defendants were aware8a of the presence of an epidemic10 of Kuru at the time of issuing the license.

2. The first four batches of pituitary hormones produced were experimental11. The Plaintiff was treated with an expired batch, number 003-02, that was subject to further experimentation12 by Professor Cox, the treating physician, with the knowledge and approval of the Defendants. CSL Batch 003-02 was administered13 to the Plaintiff in 1970, three years after its release as a commodity for sale14 for profit and at least one year past the recommended expiry date15 for similar non-experimental products produced by CSL. In 1968 this batch was found to contain pyrogens16. Pseudomonas and Hepatitis17 are amongst the other likely contaminants that are alleged be present by experts familiar with production during this period. The latter could not be excluded from the production process18. Despite this finding in 1968 CSL did not issue a recall and continued to distribute the experimental product19a, b batch 003-02.

3. Treatment after 1969 using batch 003-02 was unlawful20, 21.

4. The collection of many of the glands from corpses of Australians without consent of family members in Australia was illegal20. As the glands were mixed23 together in substantial numbers to produce the final product, sale of the product was in fact illegal as it contained pituitaries that had been unlawfully removed for sale. Without any doubt criminal negligence exists yet the Commonwealth of Australia has not instructed the Crown solicitor to prosecute any of the offenders.

With cloning, unknown slow viruses,HIV, other unknown diseases, to ignore negligence that has occurred and simply allow it to be shrugged off as "it happened too long ago" is to do so at one's own peril and to endanger the health of future generations. There has to be a penalty.

5. The injury to the Plaintiff was caused by the actions of the Commonwealth of Australia and CSL.

6. The Plaintiff did not agree to being part of an experimental program nor was informed of the risks by the defendants. The Plaintiff was not informed of the unlawful use of an expired batch. The Plaintiff did not contribute to the Defendant's negligence.

In relying on res ipsa loquitor the Plaintiff states that it is not required to conclusively eliminate the possibility of all other causes of injury as the Commonwealth of Australia now seeks to do. It is enough that it is "more likely than not"21, 7 . This document of res ipsa loquitor relies on the ordinary rules of circumstantial evidence to ascertain unusual events and it is appropriately charged when, "upon a common sense appraisal of the probative value of the circumstantial evidence, *** (the) inference of negligence is justified .

Clearly the Commonwealth Department of Health has breached its Duty of Care to the Plaintiff and the Australian public. The facts herein speak for themselves.

The Plaintiffs, Peter & Margaret Bansemer respectfully request that the court rules on the question of negligence prior to assessing the claim.

EVIDENCE OF NEGLIGENCE.

Common knowledge.

Papua - New Guinea
Pre 1975

Administered by the Commonwealth of Australia8a.
(Australian Territory)

THE KURU CONNECTION.

In 19578,8a it was common knowledge amongst the international and Australian biological science fraternity that the Transmissible Spongiform Encephalopathy, Kuru, a debilitating infectious and fatal brain disease, was present in the Fore tribes of New Guinea. The Nobel prize winner, for his work on Kuru, D.C. Gajdusek , was in New Guinea at this time and reporting to the authorities22, viz. the Territories Administration and ultimately the Commonwealth Department of Health. (CSL had employees working in Papua New Guinea together with local and international researchers researching and managing the epidemic, Kuru8b .) It is possible that some glands were transported with employees returning to Australia.

Kuru, Creukesfeldt-Jakob Disease (CJD) and Bovine Spongiform Encephalopathy ("Mad Cows' Disease") belong to the same family of spongiform encephalopathies22 that all are brain diseases and all are fatal.

Acquired encephalopathies or prion diseases include Kuru, acquired by eating or handling human tissue and iatrogenic CJD acquired by cross infection (NEJM Sept. 1996 Vol 335). These acquired diseases have an incubation time in humans that is known to be in excess of 30 years in some cases24. Kuru reached epidemic proportions among the Fore linguistic group in the Okapa region of the Papua New Guinea Highlands and was transmitted by handling or consuming human tissue during cannibalistic rituals.

The fact that more than 2,500 villagers died during Australia's Administration of Papua New Guinea from Kuru.(Richard Saville, Electronic Telegraph, April, '97 Issue #682) is indicative of an epidemic and there were other deaths due to the high mortality rate prior to the onset of symptoms that prevented any attempt to assess the true incidence of Kuru. There is mobility in modern times within the population and there is the adoption of the beliefs secretly by others in the external society who are influenced by these rituals. It is unlikely that the Fore Tribes had no contact with others in the region during this time. (Symptoms depend on the level of exposure whereby the spread of the disease would not manifest itself in that time frame).
Animism in Asia is a good example of mobility of religion.

Some of the brains or tissues taken from deceased natives, for whatever medical reason and without the informed knowledge and permission from the tribe, found their way to diagnostic laboratories8 or researchers within the Territories & where subsequently the brains had their pituitaries removed for possible dispatch to Australia.

Meanwhile in Australia, the Health Minister and his advisers who were empowered to respect the rights of their patients, considered that as it was the small pituitary gland it was not important and as such did not require authority21 from the family to remove it for sale26 to CSL. The pituitary gland is possibly the key to life and to remove it for sale or any other reason without consent of the family is not only unethical it is illegal. It is unlikely that these ethical considerations by the Commonwealth of Australia would be of a higher standard in the Australian Territory. From all accounts organ and tissue collection for international researchers was a common practice.

Regardless of whether pituitary glands were imported or not with the common knowledge that we have today in regard to the transmission and resistance of transmissible spongiform encephalopathies, the Commonwealth of Australia has unintentionally exposed the population of New Guinea and Australia to a high risk of transmission of an infectious disease in the handling of infectious materials in the laboratory environment.
BSE is a good example of the extremes necessary to prevent the spread of transmissible spongiform encephalopathies.
Cross infection would have been rampant in make shift surgeries, health centres, laboratories in both New Guinea and Australia as it could not be inactivated by normal disinfection procedures. The risk of exposure to Kuru in the production environment at CSL would be much higher than the risk of contracting CJD by contaminated Australian glands especially when the incidence of the disease in Australia is 1 : 1,000,000. Again, as the onset of symptoms determines the incubation period, recipients would have had extremely low exposure to CJD and hence a long incubation would be expected.

The question has been raised as to how CSL decontaminated their Parkville processing plant, particularly in consideration of the fact that imported glands and other biologicals including blood from Papua New Guinea may have been processed. It is already known that CJD was present in the production environment43.
A new laboratory in the UK was built to specifically provide for containment of TSE's in handling human brains and related tissues.
To date there has been no response from the Commonwealth of Australia or CSL. This is not to imply any extended liability to the Defendants but to ensure that all Australians are protected from further exposure.

Unless the infective agent is destroyed with time or by specific disinfection procedures, it still remains a threat. No one can deny this.

CSL should provide this information immediately or alternatively implement immediate decontamination procedures. This may require building a new facility - the British did not hesitate. Nor did the British hesitate destroying millions of dollars of beef in the recent BSE threat to human lives! Some leaders value human life ahead of profit.

The UK withdrew all its local blood stocks and imported them.

Clearly with the Garibadi incident the Australian Public made it clear that they did not expect health care to be compromised by Government.

The College of Pathologists in 1971 advised the Department of Health of the following:
"There is good evidence that the disease Kuru is transmissable to man and is caused by their small virus like agents which are resistant to heat, formalin and ultra violet light. It is of our opinion that pituitary glands should not be collected from patients who have died of neurological diseases of the nervous system." (Allars Report)

The Commonwealth of Australia was providing dental services to the Territories and it is known (Maurizio Pocchiari, BMJ No 7131, Volume 316) that dental procedures enhance the risk of transmission from the use of medical instruments. Normal sterilization techniques do not destroy Transmissible Spongiform Encephalopathies. This simply means that the same instruments would be used by visiting dentists back at their normal place of practice and from this the possibility of transmission of the disease is real. The risk of contaminating the operating room or dental surgery is high. (Maurizio Pocchiari, BMJ No 7131, Volume 316). The same applies to surgeons treating eye diseases. Recognized iatrogenic transmission has occurred with the use of inadequately sterilized neurosurgical instruments. (NEJM, Sept 1997 Vol 335). The Australian Government has never publicly acknowledged the implications in the failure to contain the spread of the disease by cross contamination whether real or perceived. Human to Human transmission is possible.

The standard of health care provided by the Australian Government to Papua New Guinea in its time of Administration was poor and access to the most rudimentary health care required was an onerous task5. Infection control would be difficult. Life expectancy is only 54.9 years and with the latency period known to be up to 30 years or more for Kuru whereby some die from other causes prior to the onset of clinical symptoms, the 2,500 deaths attributed to Kuru may be very conservative. Assuming that most people that subscribe to external ritualistic events usually pick these beliefs in their adult years by contact with those that support the ritual, it can not be claimed that the disease was confined to the Fore tribes - it is simply unknown due to the fact that the incubation period of infectivity relies on the concentration of the infected product. No external cult member is going to consume human tissue in the manner that the Fore tribe practiced. Due to low exposure some may be infected but may never go on to exhibit any symptoms prior to death by other causes or the manifestation of symptoms is yet to occur.

The maternal mortality rate in Papua New Guinea is one of the highest in the world with 930 deaths per 100,000. A goodly source of pituitary glands for an organisation intent on collecting these. Infant mortality rate is high at 82 per1000. More than one in eight suffer from malnutrition. Tertiary institutions, hospitals, and infrastructure are lacking basic facilities - the legacy of decades of Australian colonial rule.(WNO,International News, April 4th, 1997). The laboratory facilities to perform intricate and complicated surgical procedures were of a basic standard. This was hardly inducive to the containment of Kuru considering the knowledge that we have of transmissible spongiform encephalopathies today. If cross infection was not a problem then how did the disease run rampant through a community. Not all brains would have had Kuru.

It is clear that from the above, the collection system for medical specimens from around the country would have been far from ideal. This would not only refer to Kuru but would also include any other infectious diseases. Viral and transmissible diseases in New Guinea were by no means uncommon.
Shaded columns are direct copies of published materials.
The Disease, Kuru.

Extract from: Applied Medical Informatics, HealthAnswers

Kuru
Disease
Definition:
A neurodegenerative disease caused by a "slow virus" and transmitted, human to human.
Causes, incidence and risk factors:
Kuru is a "slow-virus" disease, once prevalent in New Guinea and rarely seen now. Kuru causes neurodegenerative changes similar to Creukesfeldt-Jakob Disease, whose distribution is worldwide. In addition, similar "slow-virus" diseases appear in sheep as scrapie, mink as mink encephalopathy, and in cows as bovine spongiform encephalopathy (BSE). Creukesfeldt-Jakob Disease has been found with increased incidence in North Africa where sheep brains and eyes are a common part of the diet.
Kuru may begin with a gait disturbance (cerebellar ataxia) and increasing incoordination. Incoordination leads to severe disability. Tremors and shivering are characteristic findings. Difficulty in swallowing and inability to feed oneself lead to malnutrition or starvation. Death occurs several years after the onset of symptoms.

Prevention:
The incidence of kuru diminished considerably with the discontinuance of cannibalism and ritualistic butchering.

Symptoms:
· Gait disturbance (cerebellar ataxia)
· Incoordination
· Swallowing difficulty

Signs and tests:
Neurologic evaluation may show characteristic changes in coordination and gait.

Treatment:
No treatment is currently available for kuru or any of the slow-virus diseases.

Expectations (prognosis):
Kuru is universally fatal.

Infectivity:
The women and children would eat the brain and other internal organs. Most men had some taboos against eating human flesh and when they did, this was usually meat and muscle. (Dr Alpers, Electronic Telegraph, April, 1997 Issue No 682). Muscle is known to be not infective.
Tribal women tend to develop Kuru in a shorter time than men. Males
(lower exposure by only eating meat and muscle) have been known to incubate Kuru in excess of 30 years and because of death by other causes the real incidence of this in this category is unknown. The theory behind this is that the onset of symptoms depends of the concentration of the infective agent in the contaminated tissue and it appears to be cumulative. I.e. the more one consumes contaminated material the quicker clinical symptoms arise. The smaller the concentration the longer the incubation time before the onset of clinical symptoms. Obviously from this, recipients of pituitary hormones in Australia would have been considered to have been exposed to low concentrations of TSE's, particularly as the batches were mixtures of glands from many sources.

Transmissibility:
"The human story for transmissible spongiform encephalopathies began with Kuru in Papua New Guinea. What we are now seeing is what is described as "high-tech cannibalism" in the production of biological materials using human and animal tissues or blood, and to the extent that we are able to transfer tissues, or extracts themselves, in the forms of grafts and transplants from one human to another, we are increasing the risk of transferring the infectious agent. This man made "high-tech cannibalism" is reflected in the higher numbers of cases of TSEs that we are now seeing in the World population.(Dr Paul Brown, National Institute of Health,Health Report,August, 1997)

Tests for TSE's.
"Not on the horizon is there a test that we can use to detect TSEs incubating in the human being who will ultimately get it many years later" .(Dr Paul Brown, National Institute of Health, Health Report,August, 1997) In respect to the new test of cerebrospinal fluid as marker for TSEs some false negatives and false positives have been found. Further analysis of large numbers of patients with neurodegenerative diseases will be needed for us to be confident in this regard.(John Collinge, NEJM, Sept 1997,Vol 335). Our own recent experience with a patient leaves us somewhat less confident about the sensitivity of this immunoassay. (Robert Jones, NEJM March,1997 Vol 336). Electroencephalography. Lack of typical EEG appearances is associated with long clinical duration and disease aetiology; the classical appearance is not seen in the iatrogenic or acquired growth hormone related cases or Kuru.(UK CJD Surveillance Unit)

NV CJD and Mad Cow's Disease in the UK.
Is NV CJD Kuru? If so is it Kuru that has been introduced in contaminated tissues from Papua New Guinea and now surfacing?

Atypical Cases:
Atypical cases of TSE's are, however, well recognized and may present diagnostic difficulties.(John Collinge, NEJM, Sept '97 Vol 335). If Kuru was imported into Australia, then because it was endemic in a different race, it would be impossible to predict the symptoms that would develop in European society. It would appear that there has not been any research to identify whether Kuru in New Guinea and iatrogenic CJD in European countries are the same.

Symptoms observed by D.C. Gajdusek whilst in New Guinea:
· Speech becomes low and blurred and finally no longer intelligible
· Marked emotionalism with excessive hilarity on slight provication
· Expressive facial appearance
· The patient remains well integrated until greater incapacity occurs
· Swallowing and chewing becomes no longer possible.
· There is no muscular weakness early in the illness.

Shaded columns are direct copies of published materials.

The Commonwealth Department of Health and Kuru.
(Establishes knowledge of Kuru)

Extract from:

"The Parliament Of The Commonwealth of Australia
Papers presented to Parliament
(and ordered to be printed)

VOL. XIX

1964-65-66"

"Most of the mission organizations provide medical services. These comprise of 76 hospitals, 140 aid-posts or medical centres, 110 welfare clinics, two hansenide colonies and one tuberculosis-hansenide hospital, which are staffed by 694 indigenous people and 225 others, including 10 medical practitioners.
Three Administration hansenide colonies, two tuberculosis hospitals and one combined hansenide and tuberculosis hospital are staffed and administered by missions on behalf of the Administration."
Cooperation with other Government and International Organizations
The Director of Public Health is a member of the Australian National Health and Medical Research Council and close liaison is maintained with the Commonwealth and the State Health authorities, including international medical research institutions, the South Pacific Commission and the World Health Organization. Regular reports of infectious diseases are sent to the two latter bodies. The Administration takes the usual control of epidemic diseases and carries out the normal international quarantine procedures."

The hospital laboratories collected specimens56 for various purposes for dispatch by whatever means available in a country with limited resources to Port Moresby and then to other countries57 for more detailed analysis depending on the nature of the problem. It would have been difficult to maintain the integrity of samples from Village to Port Moresby.

"The Papua New Guinea Medical Research Advisory Committee, which was formed in October, 1962 under the Chairmanship of Sir MacFarlane Burnet, O.M., F.R.S., Professor of Experimental Medicine at the University of Melbourne, consists of the Director Of Public Health and the Assistant Director (Medical Research) of the Territory, together with six leading Australian medical scientists.

The purpose of the Committee is to advise the Director of Public Health on matters relating to medical research, with particular attention to the following:
…………………………

(g) investigation into the incidence and causes of Kuru, a disease of comparatively recent origin among the Fore people of the Eastern Highlands District. (In this the committee will be assisted by a neurologist and two anthropologists working under long term grants.) Projects continued during the year have included work on:
……..

(g) Kuru. The majority of patients with this disease are now under continuous clinical study, in their home villages by a neurologist. Extensive highly specialized virological and other laboratory investigations are continuing at the National Institute of Health, Washington.

Since cessation of cannibalism in the late 1950s the incidence of the Kuru has declined, but a few cases still occur as a result of the long incubation period in this acquired condition.

As the mortuary attendants in Australia were paid to collect glands and as there was little exclusion criteria for the collection of glands within Australia, collection procedures in Papua New Guinea could only be considered to be, at best, of the same standard.

"Unless the body is badly decomposed it is never to late to take the gland" (CSL instructions to pathologists, Allars Report, page 72)

Report by an Australian Mortuary attendant:
"I never understood what the payment was for. I remember wondering why CSL didn't pay the hospital." (Allars Report, page77).

"the hospital had no means of ensuring that excluded categories had not been collected as the mortuary attendant often removed glands without supervision, as was usually the case"(Allars Report, page 68)

"until we(Commonwealth and CSL) hit upon the simple expedient of bribing the post-mortem room attendants…thereafter supplies were consistent and reasonable prolific."( Allars Report, page 75)

The glands were likely to be obtained from any human remains. It is possible that some of the deceased, irrespective of the diagnosis at death, were carrying Kuru and that they had died prior to symptoms developing. Indeed it is not known whether there were any separation and collection of tissues in the hospital environment that would have excluded cross infection of Kuru in tissues or blood.

· Resistance of Kuru/BSE/CJD to destruction in the environment. Chemical disinfectants (e.g. domestic bleach) waek acids, DNAase, RNAase, proteinases (including those found in the animal gut), ultraviolet light, ionising radiation, heat at cooking temperatures, and chemicals that react with DNA(psoralins/UV light, hydroxylamine, zinc ions), all have little effect on the infectivity of Kuru/CJD/BSE. High temperature autoclaving (135° C for 18 minutes) decreases the infectivity dramatically, as does the use of 1M NaOH, but neither will fully destroy CJD/BSE. It has been found to remain infective after 360° C for 1 hour or even after incineration. Internment of infective tissue in the soil for thyree years did not destroy Kuru/CJD/BSE. Some phenols and proteases will decrease the infectivity of the Kuru/ CJD/BSE but not to an adequate degree to be of value in disinfection. Most neurologists can give an account of the hospital that failed to keep track of its surgical instruments in examining contaminated material. As a result the entire instrument stock had to be destroyed and replaced. (UK CJD Surveillance Unit)

There were problems identified in the collection of glands within Australia (Allars Report) and it is difficult to imagine that the collection of glands in Papua New Guinea, or indeed in any other under developed countries, would have been any better organised. Correct preservation in transport was essential. CSL preferred to receive the pituitaries frozen. The glands could be frozen for up to 36 hours. With transportation in the 60s it is difficult to consider that the glands could have been despatched from a tribal village to Port Moresby and then subsequently delivered into CSL in Melbourne always within 36 hours. The effect of poor transportation causes bacterial growth and produces pyrogens. Some of the earlier experimental batches produced by CSL were known to contain pyrogens (CSL Chief of Quality Control, June '68). The origin of the pyrogens is not known, but coincide with the time period that glands may have been received from Papua New Guinea or from other international destination.

From the beginning of the Pituitary Hormone Program in Australia to the late 1960s it is known that the Commonwealth of Australia through the Commonwealth Department of Health had approved68 the Government owned Commonwealth Serum Laboratories to collect pituitary glands from New Guinea. :

"In 1966 the Commonwealth Department of Health granted CSL a license to import glands from Papua New Guinea, then a territory of the Commonwealth of Australia68"(Allars Report, page 49)

The pathologist from the Port Moresby General Hospital wrote at the time to CSL: October 1966. It suggests that the gland were sent:
" I have taken the opportunity of sending a small collection of pituitaries to you" (Allars Report, page 49)….
We were sending a number of different organs, different tissues to Australia for research"

Whereas the records of any such shipments are no longer available, the facts are that there are documents indicating that negotiations took place and that CSL was associated with laboratory tests being performed in the region. There were no barriers in place on arrival in Australia to screen these tissues and organs to prevent the transmission of disease. It was assumed that the Department of Health was aptly qualified to ensure that any risk was contained. (AQIS) AQIS relied on the defendants knowledge of transmissible and infectious diseases.

In addition to pituitary glands it is clearly indicated in the pathologists report above that there were other tissues being sent to Australia and yet the Commonwealth Department of Health has not yet determined whether these other tissues may have contained the infective agent, Kuru, or any other diseases known at the time. The defendants simply does not want to know about it or the information is kept in confidence and not available to the Australian Public. This occurred in respect to the information on Batch No 3 produced by CSL.

The Australian Quarantine and Inspection Service had the view that Commonwealth Department of Health staff are adequately trained in the handling and disposal of all imported biological materials to minimise the risk of an exotic disease. The Commonwealth of Australia expects that the Department Of Health Officers have been trained in regard to the risks of exotic diseases and are expected to know the procedures to prevent the spread of an exotic disease.
AQUIS, and rightly so, indicated prior to 1974 when the Act was changed, that the performance of the Commonwealth Department of Health in the execution of their duties in regard to the importation of biological materials demonstrated public confidence in their ability to use and dispose of the products from the Territories safely. There was officially no quarantine requirements because the organs were of human origin.

Clearly the responsibility rested with the Commonwealth Department of Health and their application of the knowledge that they had at the time of Transmissible Spongiform Encephalopathies.
They endorsed the collection of glands from Papua New Guinea by issuing CSL with a Licence to import the Glands.

There was no exclusion criteria, "it is desired that all pathologists in the Commonwealth (of which Papua New Guinea was part) cooperate in this project and obtain pituitary glands from every possible necroscopy subject" (Newsletter of College of Patholgists, 1968).

Within Australia, the Commonwealth Department of Health may have a case to argue pre 1977 (as is the case in the UK) in that they were not aware of any common neurological diseases such as CJD that may endanger the Australian public in the collection of pituitary glands of Australian mainland origin at that time.

This is not the case in Papua New Guinea. The Department was aware of the degenerative brain disease that was present as an epidemic in Papua New Guinea. They had a clear responsibility to protect the health of the Australian public and yet they tacitly approved of the collection of pituitary glands in a country that was known to have a pituitary related exotic disease along with other transmissible diseases prevalent in its society.

If there was such a shipment then it is most likely that these would have been handled in the same manner as other glands sourced from overseas. Indeed the transportation from Mauritius, Nova Scotia, Singapore where glands were known to have been collected is questionable (Allars report, table 3.1). The defendants advised Commonwealth pathologists that badly decomposed glands can still be used. Whereas there are no records to substantiate that the glands shipped for example from Mauritius in 1972 were ever received, their receipt was fortuitously noted in perusing CSL production records76 during the process of "Discovery" (HGH Subcommittee, Minutes of Meeting, 10th February,1972). Were it not for this, it would have been open to argument as to whether the pituitaries were ever received at all.

Because the Australian Government was the Administrator of Papua New Guinea pending its independence in 1975, the Commonwealth Department of Health was responsible for promoting health care in the region and would have been well aware of Kuru, the debilitating and fatal brain disease that was known to exist in Papua New Guinea

From the above it is clear that the Commonwealth Department of Health has put Australia at risk to an exotic disease that could have profound consequences on the health of many Australians.

Common Law definition of negligence:

"Negligence is the omission to do something which a reasonable man, guided upon those considerations which ordinarily regulate the conduct of human affairs would do; or doing something a reasonable person would not do."

Clearly any biological scientists engaged by the Defendants were expected and paid by the Australian Public to be experts and aware of international developments in respect to disease transmission. Any expert in control of disease prevention would have been aware of the need to exercise caution in respect to the collection of pituitaries from New Guinea when there was known to be an exotic disease prevalent in this country.

The problem in determining negligence in Australia in respect to contaminated pituitary hormones is that all cases have been settled out of court without the admission of negligence. There have been six cases to date. As past cases have been settled after death and there has not been the opportunity to determine negligence.

In the United Kingdom, negligence by the UK Department of Health has been established by the High Court for similar actions in respect to contaminated hormones and the presence of CJD. (Judge Moreland, UK High Court, 1997)

As with many other countries other than Australia the issue of negligence relates only to their normal collection procedures, processing and as to what they should have known at the time. These countries that have had negligence determined by the Justice system have not sourced or attempted to source their pituitary glands from Papua New Guinea where the presence of an exotic disease, Kuru, a debilitating and fatal brain disease was known.

Australia is unique in this, the Government endorsed collection of glands from an area where diseased glands where known to exist and in so doing put Australia at risk to an exotic disease.

The increased risk of an exotic disease within Australia arises from the fact that the disease is indestructable ,as shown earlier in this document, in normal circumstances and the production facility at the time did not and could not prevent the transmission of the disease.

Throughout the period and to this day, CSL have manufactured and sold human and veterinary pharmaceutical products and diagnostic products of biological origin, notably vaccines and plasma fractions. In this era, not only has CJD been identified as a contaminant, hepatitis, pseudomonas and pyrogens are all findings of the Allars Report. In addition to this of more recent times other contaminants in other products have been identified. (e.g. Factor VIII). If Kuru was imported and processed as a consequence of the Government's decision to issue a license to CSL for the processing of New Guinea glands, then it is not known how many Australians have been exposed to Kuru.

How many atypical Alzheimers cases are in fact transmissible spongiform encephalopies? Alzheimers is on the increase in Australia. Is there a connection?

The most frequent type of misdiagnosis of CJD/Kuru is in differentiating it from rapidly developing Alzheimers Disease with myoclonus.

Despite the decreasing risk of misdiagnosis, under diagnosis may still be a problem. Brain tumours, brain abscesses, Alzheimer's disease, progressive supranuclear palsy, senile dementia, stroke or Koehlmeier-Degos have been shown to coexist with patients suffering from transmissible spongiform encephalopies. An initial diagnosis of any of these diseases might still obscure a subsequent diagnosis of an associated condition such as CJD, Kuru.

In regard to what this means to the Plaintiff, Margaret Bansemer, it is not the plaintiffs' view that she should become a scientific curiousity and be subject to all and varied experiments. There is no cure and no medical treatment to assist the condition and the family is committed to managing the care for the Plaintiff in a manner that allows for some dignity. Unless there a complications there is no pain and medical treatment is sought as required.

It is the family's belief that because of the:
· swallowing difficulties,
· total loss of speech and
· much laughing at all times that it is totally out of character and other difficulties
· particularly after choking with the involuntary muscle contractions that manifest together with laughing, and
· the extended incubation period and that the batch that she was treated with

coincides with the possible importation of pituitaries from New Guinea, Kuru can not be excluded as a possible cause.

To the Department Of Health's appraisal should be added:
Atypical Transmissible Spongiform Encephalopy of origin yet to be determined.

The timing of the chain of events and the fact that recipients may have only been exposed to low concentrations of the disease during their treatment, supports the long incubation period.

The UK High Court has ruled that the UK Department of Health was negligent in respect to the management of Pituitary hormones. (Judge Moreland, UK High Court,1997).

There has been significant additional involvement by the Australian Commonwealth Department of Health and whereas there has been no opportunity to determine negligence in a court of law to this date, in consideration of this Civil action today, negligence is proven by:

Res Ipsa Loquitor (the facts speak for themselves)
The facts detailed above clearly demonstrate negligence.

The above facts relate to the Defendants' knowledge of Kuru and its exposure of this disease to the Australian public real or perceived.

*********

The next issue of negligence where again Res Ipsa Locquitor prevails is described below:

PROCESSING THE PITUITARY GLANDS BY CSL.

The Department of Health indicated to the Plaintiffs that the treatment was in the late 60s after referral to the QEH/Professor Cox records. It was only because the Plaintiffs had documented evidence that the Plaintiff Margaret Bansemer was treated much later did they accept the Plaintiffs' dates of treatment. The Commonwealth Department of Health initially informed the Plaintiff Margaret Bansemer that she was not officially "on the program". Clearly the Department did not have any records in respect to the Plaintiff or it chose to manipulate the dates for its own advantage. The advice given by the Department was misleading and incorrect.

The batch number that the Plaintiff Margaret Bansemer was treated with was batch number 003-02 and was released in November , 1967. This was an experimental batch. CSL had a policy of a two year expiry date for similar non experimental commercial products. As part of the Code of Good Manufacturing Practice and common sense, quite clearly this batch should have been discontinued in 1969. Instead it was used well beyond its expiry date.(Allars Report.)(CSL notes)

In June1968 the experimental batch 3 was identified as containing pyrogens and there was no recall. Other contamination in CSL batches were identified in the Allars Report. CSL continued distribution without action in regard to these problems. (CSL report June, 1968). CSL and the Department showed no regard to the health of the Australian public who were to be the recipients of this contaminated experimental batch.

The Plaintiff Margaret Bansemer in the early days of pregnancy in 1970 was inflicted with an acute ear infection that subsequently lead to her being afflicted with Tinnutis (ringing in the ears). This has been clearly identified in later years as a result of an acute ear infection.

The Plaintiffs have evidence to support that such an infection could have occurred as a result of the pyrogens and pseudomonas known to be present in batch number 003-02.

The Plaintiff wishes to instruct the court that the Plaintiff has been further harmed by the Defendants and although no monetary compensation is sought the Plaintiff seeks a judgement of negligence of the highest order.

The Plaintiff, Margaret Bansemer, developed a severe neurological disorder in July, '97. She was referred to a neurologist by her local doctor.

The neurologist Dr Waddy and the conferring neurologist Dr Burrow diagnosed the most likely cause of disease to be Creukesfeldt-Jakob Disease or more simply a transmissible spongiform encephalopathy as prior to death the nature of this can not be determined.

The Commonwealth Department of Health and CSL accepted the diagnosis received by the consulting neurologists that the Plaintiff, Margaret Bansemer is in the absence of any other diagnosis is likely to be suffering from CJD for the purpose of the Victorian Supreme Court settlement. (Professor Judith Whitford October, 1997)

For the Commonwealth Department of Health's involvement in this manner, all care costs were to be negotiated through a Trust Fund set up for this purpose. It was supposed to be a non-litigation Trust Fund for those recipients that develop neurological symptoms that may be CJD.
History demonstrates that this is far from the case and the access to the fund has been continuously under litigation every day from July last year.

Professor Whitford had already advised the Government that CJD was a possibility and that there was no other test available prior to death that could establish whether or not CJD was the cause.

The Commonwealth Department of Health again failed in its Duty of Care when it failed to disclose to the family the recommendations of the NHMRC in regard to infection control for the management of victims of CJD. This is a Government Department that is funded by the Taxpayer for the benefit of all Australians. They are indeed responsible for ensuring that they do not expose Australians to any unnecessary risk.

The Department states that it has no obligation to inform the family of this risk of infection of a fatal disease. Unfortunately if these matters were treated more seriously by the Department then it may well be that it would not now find itself in this situation. The Department of Health exists because of the taxpayers' desire to ensure that the health of all Australians is not compromised. They are Public Servants and therefore have a duty of care to the Public, their employers.

They have breached their duty of care by claiming that the Commonwealth of Australia and CSL have no duty of care to the Australian Public. A Government Department should never deny that it does not have a duty to disclose information that may impact on the health of the individual.

The carer, Jason Bansemer, was exposed to possible cross infection in the period that the Department was failing to adequately address the question of care. Jason was paid by the Commonwealth Department of Health directly and the Department of Health had a duty of care to inform him of the risks. If it can organise payment it can surely organise the moral obligation in respect of its duty to inform and disclose risk.

The Department of Health is now unable to determine at any time in the future as to whether Jason Bansemer has contracted CJD through exposure or has contracted it through maternal transmission.

The Department has indicated that it does not agree that the care requirements have increased. The Plaintiffs have invited the Department to reassess the care requirements by engaging an occupational therapist to reconfirm the level of care as required to avoid any later dispute.

The Department and the Australian Government Solicitor have repeatedly stated that they are not responsible for the care arrangements that the family makes and yet they seek to regulate payment and the nature in which the care is provided.

The American Vaccine Trust Fund is of similar nature and has the same problems.

Quite clearly, the provision of a Trust Fund without implied negligence does not benefit the Plaintiff in any way. In fact it reduces the quality of life substantially due to the increased stress level to have to react almost daily to the barriers that the Department has erected.

The Plaintiff Margaret Bansemer has accessed the Trust Fund at the Defendants initial request and the Department of Health has continued to build barriers to prevent their exposure increasing by ensuring that they avoid their obligations of care. As the guilty party they are making decisions that they have no right to make.

Whereas the Plaintiff by continual and onerous negotiation with the Department of Health has successfully recouped costs, the Commonwealth Department of Health has suspended access to the Trust Fund from the 31st of March.

The Plaintiffs consider that this is in part due to the Defendants view that the symptoms are not necessarily consistent with the previous five deaths in Australia as death has occurred much sooner.

The previous cases where later batch numbers were used may in fact be iatrogenic CJD. The Plaintiff's case may be Kuru and as such may be have different symptoms. Either way, World literature suggests that there are many atypical cases of the various TSE's.

All of the literature indicates that there is no definitive diagnosis, yet the Department has now chosen to obtain a definitive diagnosis93 prior to further access to the Trust Fund.

The Commonwealth Department of Health in denying access by the Plaintiff to the Trust Fund states that negligence is not proven or admitted and therefore access to the Trust Fund is at their discretion.

The Plaintiffs state that :

Res Ipsa Loquitor (the facts speak for themselves)
The facts detailed above clearly demonstrate negligence

The Plaintiff respectfully seeks the Court to determine negligence on the basis of fact and to instruct that the Plaintiff Margaret Bansemer is eligible to access the Trust Fund as of the date of Settlement in the Victorian Supreme Court.

Footnote:

The Department of Health was the architect of the Trust Fund and the Plaintiff had no input into this in any way. They agreed to subjective diagnosis.