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.
