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Report of the Ministerial Inquiry into the Under-reporting of Cervical Smear Abnormalities in the Gisborne Region

10. Term of Reference Seven

Any other issues which the Committee believes to be of particular relevance:

10.1 The Committee has interpreted this term of reference which permits it to report on other issues of particular relevance to which in the context of terms of reference one to six issues must be read in context with the other more specific terms of reference in keeping with the ejusdem generis rule. It follows then, that the meaning of the more specific terms of reference limit the apparently general meaning of term of reference seven.

Compensation For Women Affected

10.2 Counsel for the women affected made submissions to the Committee that under terms of reference seven and eight the Committee should "urge the Government to consider an appropriate method of compensating all those women who establish bona fide claims". This submission is difficult for the Committee to deal with. It is aware that the women affected have been severely injured by the unacceptable under-reporting.

10.3 However, it considers that there are legal barriers which prevent the Committee from making such a recommendation. First, it is questionable whether or not any recommendation the Committee might make on compensation is relevant to the terms of reference. Although term of reference seven is very wide, in the Committee’s view the general language of this term of reference must be read in context with the other more specific terms of reference in keeping with the ejusdem generis rule. It follows then, that the meaning of the more specific terms of reference limit the meaning of term of reference seven.

10.4 The Committee has not been specifically directed to consider the impact of the consequences of the unacceptable under-reporting on the women affected. The essence of the terms of reference are to look at whether or not there has been under-reporting, if this has occurred to report on what has led to it, and then to inquire into what changes have already occurred and what changes still need to occur to reduce the likelihood of unacceptable under-reporting occurring in the future. The impact of the under-reporting on the women affected falls outside the specific terms of reference. Therefore, insofar as the specific terms of reference limit the general language of term of reference seven, it may be that the question of compensation is a topic which is too remote for the Committee to consider under that term of reference.

10.5 Term of reference eight directs the Committee to take into account s.4 of the Health & Disability Services Act. That section says nothing, which is relevant to questions of compensation.

10.6 Secondly, and more importantly, there is the conundrum that a claim for compensation as a result of medical misadventure or personal injury presents in the context of New Zealand’s Accident Compensation legislation. Since 1972 New Zealand has followed a legislative scheme which is based on the philosophy of not finding fault or holding persons accountable under the common law for the injuries that they may cause others on the ground that accidents are a fact of modern life; and that it is for the community to carry this burden rather than to use common law actions to make the culprit compensate the injured victim. The current prohibition against bringing legal proceedings to recover compensation for personal injury is to be found in the Accident Insurance Act 1998.

10.7 Section 394 of the Accident Insurance Act 1998 prohibits anyone in New Zealand from suing for damages arising directly or indirectly out of personal injury covered by the Accident Insurance Act or personal injury covered by the former Acts (being the Accident Rehabilitation and Insurance Act, 1992, the Accident Compensation Act 1982 and the Accident Compensation Act 1972). Section 39 provides that a person has cover under the Act if they suffer a personal injury in New Zealand that is caused by an accident or by medical misadventure. Section 29 defines a personal injury. It includes: death, physical injury and any mental injury, which is a consequence of a physical injury. Under this legislation personal injury by accident and personal injury by medical misadventure are two discrete categories of injury. The same injury cannot be both a personal injury by accident and by medical misadventure. It was possible for a personal injury to qualify as both under the Accident Compensation Acts of 1972 and 1982. Section 28 defines an accident as including: a specific event or series of events that involves the application of a force or resistance external to the human body. Section 35 defines personal injury caused by medical misadventure as being a personal injury caused by medical error or medical mishap. A medical error is defined as a failure of a registered health professional to observe a standard of care and skill reasonably to be expected in the circumstances. It includes a negligent failure to diagnose an insured’s medical condition. Medical mishap is an adverse consequence of treatment. Medical error involves much the same tests as the common law applies in negligence claims based on medical misadventure. Thus the factual circumstances which will give rise to a successful common law claim will also meet the Act’s definition of "medical error". This means that any injury the women affected have suffered which would entitle them to compensatory damages under the common law of negligence, or any other pertinent civil cause of action, will also come within the scope of s.394 of the Accident Insurance Act, and so they will be prohibited from bringing any such claim.

10.8 The common law of negligence has traditionally followed a philosophy of finding and apportioning fault on those persons who are found to have caused injury to another, with the result that those who are found to be at fault are liable to compensate the injured victim for the harm suffered. If the common law principles of negligence (and other pertinent common law actions) were still available in New Zealand for cases of personal injury, it is very likely that the women affected would bring legal proceedings for compensatory damages against Dr Bottrill, Gisborne Laboratories Limited and the Crown, which would be sued on behalf of the Department of Health/Ministry of Health and the Minister of Health. However the no fault principle of the Accident Compensation legislation prevents any such claims from being brought.

10.9 The Committee is aware that in Childs v Hillock [1994] 2 NZLR 65, a woman who suffered pelvic inflammatory disease as a result of using certain intra-uterine contraceptive devices sued the medical practitioner and the Minister of Health, Director-General of Health and the Department of Health for negligently approving and permitting the distribution of these devices in New Zealand. The Crown defendants were sued for compensatory damages. Without making any examination of the merits of the claims, the court struck out the claims against the Crown defendants on the basis that they were for compensatory damages and the Accident Compensation legislation did not permit such claims to be made. In Green v Matheson [1989] 3 NZLR 564, Mrs Matheson who was one of the women badly affected by what has come to be known as the unfortunate experiment at National Women’s Hospital (which was the focus of the Cartwright report), brought proceedings in negligence against Dr Green, Dr Bonham, Dr Warren, the Auckland Hospital Board and the University of Auckland. She alleged three causes of action : trespass to the person, breach of fiduciary duty and negligence (including negligence arising from administrative shortcomings resulting in a lack of an informed consent). Mrs Matheson claimed compensatory and exemplary damages. Her claim for compensatory damages was struck out by the court on the ground that all the consequences for which she was suing were physical or mental consequences within the meaning of the Accident Compensation Act 1982. They were all part of the alleged medical misadventure and the damages claimed arose directly or indirectly out of it. For that reason, Mrs Matheson could not sue for compensatory damages as a result of the damage she had suffered, which included contracting cervical cancer as a result of a failure to treat properly the pre-cancerous abnormality of her cervix. The cases of Green v Matheson and Childs v Hillock were used as test cases to determine if a legal claim could be brought and in that sense they were representative of other claims brought by other women who had suffered the same injury.

10.10 In Brownlie v Good Health Wanganui (Unrep 10/12/98 CA 64/97) a claim in negligence was brought by eighth plaintiffs (the majority of whom were women) who, between 1982 and 1993, had each had a histology sample taken for pathological examination and diagnosis for abnormality, particularly for the presence of cancerous or pre-cancerous conditions. The pathologist who carried out the examinations detected no malignancy or pre-cancerous condition, and the plaintiffs were so advised. Subsequently, following an audit of the pathologist’s work and the hospital’s laboratory practices and procedures, the hospital became aware that a number of patients, who had undergone surgery since 1982, may have been misdiagnosed as a result of incorrect pathology reports prepared by the pathologist. There was a possibility that some 54 persons, (including the eight plaintiffs), may have been misdiagnosed during those years. The remedies the eight plaintiffs sought in their claim included compensatory damages for the injuries they had suffered as a result of their disease not being detected, and therefore going untreated. Their claims for compensatory damages were struck out on the ground that such claims were prohibited by the Accident Compensation legislation.

10.11 Because the Accident Compensation legislation removed the payment of lump sums for pain and suffering in 1992, the women affected will be eligible for little, if any, financial entitlements under the legislation. Those women who are not wage earners will not be eligible for earnings related compensation. Medical treatment and rehabilitative care are the most that the women affected are likely to receive. In other jurisdictions, if they were able to establish claims for compensatory damages they would be likely to receive large financial payments.

10.12 The submission made by counsel for the women affected that the Committee should urge the Government to consider an appropriate method of compensating the women, is in essence a submission that: the Committee should urge the Government to treat the women affected differently from any other person who suffers personal injury as a result of an accident or medical misadventure; that in this particular instance the Committee should urge the Government to depart from the general philosophy of Accident Compensation legislation which prevailed in this country since 1972, and which in the past has prevented women like Mrs Matheson, Ms Childs and Mrs Brownlie from suing for compensatory damages.

10.13 Equal treatment under the law is a keystone principle of our legal system. It is difficult to see any reason why in principle the women affected by the unacceptable level of under-reporting at Gisborne should be treated differently from the women in Childs v Hillock and Green v Matheson, the plaintiffs in Brownlie v Good Health Wanganui, or indeed any other person in New Zealand who suffers a personal injury. Because a recommendation to pay compensation would be contrary to the legal principles which have been operating in New Zealand since 1972; and it would mean the women affected were treated differently from other persons who have suffered a personal injury either by accident or by medical misadventure the Committee considers it is unable to make any recommendation on compensation.

10.14 An additional reason against the Committee making a recommendation to compensate the women affected is that the Committee conducted its hearings for the purpose of answering the terms of reference. An inquiry under the law of negligence would involve looking at: the existence of a duty of care (which involves questions of proximity and public policy), causation, remoteness of damage, contributory negligence and the negligence of third parties. None of these issues have been directly traversed in evidence, or submissions. Therefore, the Committee is in no position to make any comment on whether or not the women affected have established, or can establish, bona fide claims. Furthermore, to attempt this exercise would involve the Committee commenting on who it considered to be at fault. It is beyond the power of this Committee of Inquiry to make findings of blame.

10.15 It is possible in New Zealand to bring common law actions in negligence and other causes of actions for exemplary (punitive) damages. This is possible because exemplary damages are different from compensatory damages. Exemplary damages, unlike compensatory damages, are not awarded to compensate the plaintiff, but to punish the defendant for high-handed disregard of the plaintiff’s rights, or similar outrageous conduct. For this reason the New Zealand courts have found that claims for such damages are outside the scope of the Accident Compensation legislation. It is not appropriate for the Committee to make any recommendations in respect of payment of moneys which could be seen as akin to exemplary damages. First, there has been no request from the women affected for such damages. Their submission is to urge the Committee to recommend to the Government a payment of compensation. Secondly, as the purpose of exemplary damages is to punish the defendant, any recommendation must be based on findings of fault and blame. It is not appropriate for this Committee to make findings of fault or blame in respect of any person.

10.16 The Committee has provided a lengthy account of why it cannot recommend compensation for the women affected because it considers they are entitled to a full explanation. They relied on a screening programme to protect their health. In this instance the screening programme has been unable to deliver to them the benefits which would usually flow from a well-designed and well-run screening programme.

Access To Maori Women’s Data And The Kaitiaki Regulations

10.17 In the course of the public hearings the Committee learned that there have been occasions when obtaining access to Maori women’s data on the National Cervical Screening Register has been delayed by the National Kaitiaki Group which is responsible for managing applications under the Kaitiaki Regulations. These regulations control access to aggregate non-identifiable data of Maori women on the Register. The Ministry of Health now submits that these regulations have not been responsible for the delays in obtaining this data.

10.18 However, the Committee has seen evidence which shows that at times the Kaitiaki Regulations have frustrated the Ministry’s ability to utilise Maori women’s data. A Ministry memorandum of April 1996 headed National Cervical Screening Programme – An Overview comments on the Kaitiaki Regulations. Under the heading "Protection of Data" the Ministry’s memorandum records that because of the sensitivity around the personal nature on the Register, and a desire to encourage Maori women to accept the Register, s.74A of the Health Act had been introduced to allow special treatment of women’s data on the Register, and subsequently under this section the Kaitiaki Regulations were promulgated. The Kaitiaki Regulations were initiated as a compromise that was reached at the time the Register changed from opt-on to opt-off. Maori women at that time were concerned to have special protection for their data because of its significance to them and the importance of the sanctity of Te Whare Tangata. Their first choice would have been to have an entirely separate register; the Kaitiaki Regulations were a compromise.

10.19 The memorandum notes that one impact of the Kaitiaki Regulations has been to reduce the supply of all data by ethnicity on the basis that this would, by default, identify Maori data. It then states that Pacific Island women are now seeking similar protection, and that although the Minister was opposed to a regulation, a group had been set up to approve requests for the release of Pacific Island data on an interim basis.

10.20 Under the heading "Monitoring and Evaluation" the Ministry’s memorandum refers to what is described as "lock-out" of ethnic data and states that this has frustrated the Cervical Screening Advisory Committee.

"Because of the way the Programme has developed, there have been significant problems extracting data to report on progress. With reconfiguration it is expected that the situation will improve significantly. This lack of data (compounded by the lock out of ethnic data) has been frustrating for the Cervical Screening Advisory Committee and also identified as an obstacle by the Committee reviewing screening recommendations. CSAC’s terms of reference explicitly include advice on monitoring and evaluation. Longstanding Committee members are of the view that they have given all the advice on this they can, but the Ministry has failed to act on it. The review of cervical screening policy has been done in the absence of data on current performance of the National Cervical Screening Programme. (The usefulness of data would be limited in any case by the fact that prior to the introduction of an opt-off policy, numbers on the Register were too small to be of much use for monitoring.)

10.21 The Committee also learnt in evidence from Ms Earp of the Ministry of Health, that even Ministry of Health officials have to apply to the Kaitiaki Group to access aggregate data on Maori women from the Register. Professor Skegg was asked to comment, as an epidemiologist, on these circumstances. He saw them as inhibiting the delivery of a high quality programme to Maori:

"Q The Committee of Inquiry has learnt from the witness Ria Earp that even the Ministry of Health has to apply to the Kaitiaki Group to access summary data on Maori women. From your experience as an epidemiologist, given that this information is health information on registers run by the Ministry of Health, what comment do you have to make on the requirement that the Ministry itself must apply to the Kaitiaki Group for permission to access the data.

A I can see that this is a legal requirement under the provisions made, but I must say I think it was unwise for them to be framed in that way. My concern is that, I suspect that, although I cannot speak for Maori women, that many Maori women would be concerned if mechanisms such as these were inhibiting the delivery of a high quality programme to Maori as well as non-Maori."

Professor Skegg also told the Committee that he was aware that some proposals for evaluating the Programme were not going ahead in their full form because the Kaitiaki Group had declined access to the information.

"Q Does the restriction the Kaitiaki regulations place on accessing Maori women’s data, summary data, have a detrimental impact on the Screening Programme?

A I think it does. I think that probably researchers and people involved in health evaluation are inhibited from even asking for the information because they are aware that there is this mysterious group that controls it. I am conscious today even some proposals for evaluating the Screening Programme are not going ahead in their full form because the Kaitiaki Group has declined access to information which does not identify women."

10.22 The Committee understands the particular sensitivity of Maori women to strangers having access to data on the National Cervical Screening Register. It also understands Maori concerns that aggregate data of Maori women may be applied in a way which reflects negatively on Maori. However, at the same time, it needs to be realised that for the Programme to function effectively the more data that is available to a person working on the Programme, and indeed other medical researchers, the more effective the Programme will be.

10.23 The Committee is concerned to learn that Ministry of Health officials who were working in the Programme could not access aggregate Maori data. The rate of cervical cancer in Maori women is far higher than in other women. It is only by learning as much as possible about the incidence of cervical cancer in Maori women that this disparity can be addressed, and hopefully reduced. Once again, the Programme’s needs in order for it to function effectively as a medical programme appear to be at odds with non-medical philosophies and concerns. The extent to which the Programme’s medical features are compromised for non-medical reasons has an impact on how it operates as a medical programme. This has to be accepted. The Committee thinks that it would be worthwhile, when the question of access to now-protected information is reconsidered, that the question of access to aggregate data of Maori women be looked at afresh. Consideration needs to be given to whether or not the sentiments expressed in the Ministry’s memorandum of April 1996 are correct, and whether there is a detrimental impact on the Programme. If so, Ministry officials should have better access to this data.

10.24 One possibility that was put forward in submissions to the Committee is that an exception be made to the regulations where research is being done under the Programme for the benefit of the Programme, for example the evaluation to be carried out by the independent evaluation team, or an audit of the type suggested by Professor Skegg, or even simply the compilation of statistical reports for the Programme. This approach would mean that the focus of the Kaitiaki Group would be on applications for release of data to "outsiders" where the need for protection is probably at its greatest, rather than to those who have an obvious and legitimate need of the information to ensure the running of the Programme.

Programme’s Inability To Control Smear-takers

10.25 In the course of reading material concerning proposed legislative change to s.74A of the Health Act, the Committee has discovered an issue which it considers to be of particular relevance to Term of Reference Seven.

10.26 A memorandum the Ministry prepared for the Cabinet Social Policy and Health Committee to discuss options to overcome the barrier s.74A presented to the planned national evaluation raised particular concerns for the Committee. One of the suggested means of overcoming the section’s prohibition on access to information was to obtain routine consent to use of now-protected data for audit purposes at the time women enrolled on the Register. The memorandum further states, however, that there are approximately 5,000 smear taking providers and that most of them do not have a contractual relationship with the Programme and, therefore, they cannot be compelled to use the appropriate National Cervical Screening Programme form. This memorandum suggests to the Committee that the Programme has no means of controlling the information smear takers give to women about the Programme, since it has no confidence smear takers will properly inform women that if they are enrolled on the Register their information will be available for monitoring and evaluation purposes.

10.27 This raises a wider issue. If the Programme cannot control what information smear takers pass on to women, how can the Programme be certain that smear takers are properly informing women of their right to opt-off the Register? The essence of the Programme, since the Register became opt-off, is that all women are enrolled on the Register, except for those who decide to opt-off. This requires all women to be told of their right to opt-off. Furthermore, in order for women to make an informed choice about whether or not to opt-off they need to know what is entailed in remaining on the Register. They depend upon their smear takers to give them this information. But, it seems the Programme has no control over what smear takers tell women. Thus there are probably smear takers who are not telling women of their choice to opt-off the Register or if they are, they may not be fully informing them about what the decision to remain on the Register entails. Therefore women are not able to make an informed choice. The implied consent to be on the Register which is derived from a woman not deciding to opt-off the Register may not be an informed consent. The Committee considers this issue requires urgent attention.

10.28 In the course of the Inquiry the Committee learned that smear tests for women in Gisborne are now being read at Medlab Hamilton Limited (Medlab Hamilton). This company purchased the business of Gisborne Laboratories Limited and now runs it as Gisborne Medical Laboratory Limited (Medlab Gisborne). Cervical cytology is no longer read at Medlab Gisborne (the former Gisborne Laboratories Limited). The Committee learned that the records of women patients of Gisborne Laboratories Limited were stored at Medlab Gisborne. The storage was not ideal, and there seemed to be no way by which Medlab Hamilton could readily retrieve these records.

10.29 Medlab Hamilton carries out the practice of reviewing previous smear tests when it reads a smear test as abnormal. The advantage of this exercise is that it may reveal any earlier smear tests that have been misread. Although Medlab Hamilton carries out this practice in respect of women patients whose records are stored at Hamilton, the "look-back" exercise is not regularly carried out for those patients from Gisborne whose smears are read at Hamilton, but who are likely to have records of earlier smears stored at Gisborne. The Committee understands that this is because the records are not easily retrieved. This means that for those women the opportunity to carry out a look-back exercise to see whether or not earlier smears have been misread is reduced.

10.30 The Committee was concerned to hear this. It considers that a legal obligation is needed to require the vendors of laboratory businesses (either through the sale of that laboratory’s business or through a sale of shares in the company owning the laboratory), to be held legally responsible for ensuring that the records of their former patients are stored and archived in such a way that the information is readily accessible and retrievable by any laboratory which subsequently reads these patients’ smear tests. How this legal obligation can be imposed on the vendors will need to be determined. Any present absence of legal authority to impose such an obligation should not be a deterrent.

 

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