Moylan v Nutrasweet Co
[2000] NSWCA 337
•24 November 2000
NEW SOUTH WALES COURT OF APPEAL
CITATION: MOYLAN & ORS v THE NUTRASWEET COMPANY & ORS [2000] NSWCA 337
FILE NUMBER(S):
40175/99
40176/99
40177/99
40178/99
40179/99
40180/99
40181/99
40182/99
40183/99
40174/99
HEARING DATE(S): 29 August 2000, 30 August 2000, 31 August 2000, 1 September 2000, 4 September 2000, 5 September 2000, 6 September 2000, 7 September, 8 September 2000
JUDGMENT DATE: 24/11/2000
PARTIES:
Sonya Lee Moylan, Margaret Ann Lane, Margaret Orders, Brenda Southren, Sharon Gai Robertson, Fiona Mary Denzin, Karen Cynthia (Tabbah) Ottaway, Deborah Lea Gentle and Wendy Janene Lee - Appellants
The Nutrasweet Company, Monsanto Australia Limited, SCI Corp and G D Searle & Co - Respondents
JUDGMENT OF: Sheller JA Beazley JA Giles JA
LOWER COURT JURISDICTION: Supreme Court - Common Law Division
LOWER COURT FILE NUMBER(S): 109027/90, 11890/89, 12141/89, 12142/89, 13864/89, 13983/89, 11354/90, 123255/90, 13528/93
LOWER COURT JUDICIAL OFFICER: Bruce J
COUNSEL:
Appellants - P Cashman/R Gilsenan
Respondents - B W Walker SC/CB Loveday/SS Clark
SOLICITORS:
Appellants - Maurice Blackburn Cashman
Respondents - Clayton Utz
CATCHWORDS:
COURTS AND JUDGES - Judgments - Duty to give reasons - Adequacy of reasons - Damages claim for personal injury - Where dispute involves an intellectual exchange between expert witnesses - Where judgment largely consisted of parties’ submissions - Where delay in giving judgment.
LIMITATION OF ACTIONS - Extension of limitation period - Exercise of discretion under Limitation Act 1969, s60G - Onus - Requirement of whether "just and reasonable" to grant extension.
PROCEDURE - Appeal and new trial - Whether Court of Appeal should give directions as to form of new trial.
PROCEDURE - Costs - Indemnity costs - Where defendants conceded to new trial during appeal - Costs of appeal grounds not argued. - D
LEGISLATION CITED:
Health and Other Services (Compensation) Act 1995
Limitation Act 1969
Ritchie’s Supreme Court Procedure
Supreme Court Act 1970
Trade Practices Act 1974
DECISION:
(a) The defendants to pay the plaintiffs’ costs of the liability appeal on grounds 2 and 5 of the synopsis of grounds of appeal but to have a certificate under the Suitors’ Fund Act 1951 if so qualified
(b) The costs of the hearing of the liability proceedings before Bruce J will be in the discretion of the Judge re-hearing the proceedings or in the discretion of a Judge of the Common Law Division
(c) The plaintiffs to pay the defendants’ costs of the limitation appeals but to have a certificate under the Suitors’ Fund Act if so qualified
(d) The costs of the hearing of the limitation applications before Bruce J will be in the discretion of the Judge re-hearing those applications or in the discretion of a Judge of the Common Law Division.
JUDGMENT:
THE SUPREME COURT
OF NEW SOUTH WALES
COURT OF APPEAL
CA 40175/99, 40176/99,
40177/99, 40178/99, 40179/99,
40180/99, 40181/99, 40182/99, 40183/99, 40174/99
SHELLER JA
BEAZLEY JA
GILES JA
Friday, 24 November 2000
MOYLAN & ORS v THE NUTRASWEET COMPANY & ORS
JUDGMENT
SHELLER JA:
INTRODUCTION
The nine plaintiffs in the actions the subject of these appeals (the “liability proceedings”) were selected from about two hundred and sixty five actions begun in the Supreme Court to recover damages for injury said to have been caused by the use of intra uterine devices (“IUDs”) known as Copper 7 (“Cu-7”), Gravigard and Mini-Gravigard (“Mini”). The defendants were the manufacturer and suppliers of these IUDs. The plaintiffs were selected as “lead” plaintiffs by a process determined by Smart J in a decision given on 21 February 1994. In the course of his reasons for judgment, Smart J said:
“The overall result of the selection process must be a group of lead cases which is fair and is likely to lead to the remainder of the cases being settled. Expedition and the curbing of expense are important. Both parties must feel that they have participated in the selection process and that a reasonable method, albeit, not a perfect method has been adopted. Both parties recognised that any selection process may lead to an unsatisfactory or unhelpful group of cases and that the ultimate result of the selection process would have to be reviewed and be subject to any further order which the court might make.”
On 22 February 1999 Bruce J delivered judgment in applications by the plaintiffs pursuant to s60G of the Limitation Act 1969 (“the Limitation Act”) to extend the limitation period (“the limitation applications”) and judgment in the liability proceedings. In the first he held that the limitation period for each of the nine plaintiffs’ causes of action should be extended. In the second he gave judgment for the defendants in all the actions. On 4 March 1999 Bruce J gave further reasons in the limitation applications dealing with costs and made orders extending the limitation periods.
The plaintiffs appealed against the judgments for the defendants in the liability proceedings (“the liability appeal”). Grounds 2 and 5 of the liability appeal were delay in the delivery of judgment and the complete failure to consider or deal with material evidence of numerous witnesses. The defendants filed a notice of contention in the liability appeal and applied for leave to appeal against the orders made in the limitation applications on grounds which included the failure to give adequate reasons for exercising the discretion under the Limitation Act (“the limitation appeals”). Various other errors were said to have been made in the reasons for judgment.
The nine plaintiffs were Margaret Ann Lane, Margaret Orders, Brenda Southren, Sonya Lee Moylan, Sharon Gai Robertson, Fiona Mary Denzin, Karen Cynthia (Tabbah) Ottaway, Deborah Lea Gentle and Wendy Janene Lee. Together I shall refer to them in these reasons as “the plaintiffs”.
Each plaintiff had had one or more than one IUD manufactured and supplied by the defendants inserted in the period between 1975 and 1986. The first of such IUDs, the subject of these actions, were inserted in each of the nine plaintiffs between 1975 and 1980.
The four defendants to each of the actions were the Nutrasweet Company, Monsanto Australia Limited, SCI Corp and G D Searle & Co. Together I shall refer to them in these reasons for judgment as “the defendants”.
On 31 July 1992 McInerney J made orders permitting the plaintiffs to amend their statements of claim pursuant to Pt 20 r4 of the Supreme Court Rules to join SCI Corp, Monsanto Australia Limited and G D Searle & Co as defendants and to substitute the name “The Nutrasweet Company” for the name of the first defendant in the statement of claim, G D Searle and Company. The defendants were all members of what is now called the Monsanto Group of Companies.
The Nutrasweet Company, under the name G D Searle and Company, carried on all aspects of the business associated with the Cu-7 at all times at least up until 24 May 1978. Subsequently, it changed its name to The Nutrasweet Company. Monsanto Australia Limited, then called Searle Australia Pty Limited, carried on the business of distribution, sales, promotion and marketing of the Cu-7 and provided information and warnings for health care providers and users within Australia at all relevant times.
By order made by this Court on 7 September 2000, SCI Corp was, on the application of the defendants’ counsel and with the consent of the plaintiffs, removed as a party to the proceedings without prejudice to any further application the plaintiffs might be advised to make in relation to the parties to the proceedings. SCI Corp was alleged to have carried on the business associated with Cu-7 from 24 May 1978 to 1 January 1986. The fourth defendant, which changed its name to G D Searle & Co on 2 January 1986, carried on that business from 1 January 1986.
In a three page summary at the beginning of his judgment in the liability proceedings, Bruce J found that the plaintiffs had each suffered considerable physical and emotional injury as a result of contracting pelvic inflammatory disease (“PID”) which had affected their fertility. They had sued the defendants “essentially on the basis that the manufacturer was negligent in the design of the device and failed to warn them of risks to their health of which they were aware”. As is apparent from this part of the summary, Bruce J found that the plaintiffs had contracted PID which had affected their fertility. As it happens it was not the case of the plaintiff, Mrs Gentle, that her fertility was affected.
THE HEARING
Evidence before Bruce J in the liability proceedings began on 24 January 1996 and finished on 13 September 1996. Oral submissions were made between 27 October 1997 and 23 December 1997 when Bruce J reserved his decision. He gave judgment fourteen months later. According to the plaintiffs, a substantial number of witnesses gave oral or written evidence or both and most were cross-examined. The transcript of oral evidence and submissions exceeded 8,000 pages. Bruce J received several thousand pages of written submissions together with additional voluminous documentary exhibits. Bruce J said that the documentary evidence comprised approximately fifteen “lineal metres of folders of exhibits” and the written submissions comprised approximately three “lineal metres of folders of submissions and supporting documents”.
In the judgment summary Bruce J set out his conclusions as follows:
“It was common ground that injury of the type sustained by the plaintiffs could be sustained without the use of the defendants’ device and that it could also be sustained with the use of the defendants’ device. The plaintiffs submitted that if they showed any negligence on the part of the defendants which materially increased the risk to the users of the devices then that was sufficient to establish causation of their injuries so as to entitle them to succeed against the defendants unless the defendants established that the injury was due to some other cause.
In my view this is not the law and until it is changed by either a decision of the High Court of Australia or by the Parliament of New South Wales it is necessary for the plaintiffs to establish that their injuries were, on the balance of probability, caused by or materially contributed to by the negligent acts of the defendants.
In my view the plaintiffs have not established that the defendants were negligent in any material way nor that the actions of the defendants caused or materially contributed to the injuries to the plaintiffs.
Further, in my view, the plaintiffs have not established any breach of any duty to warn the plaintiffs of any matter.
There will be judgment for the defendants in each of the cases.”
The defendants submitted that the first paragraph accurately described the plaintiffs’ case as one of increased risk to users.
THE APPEALS
The synopsis of the plaintiffs’ grounds of appeal contained fourteen grounds. An order was made that the following of those grounds be heard separately and first.
“1.Judicial incapacity or reasonable apprehension of judicial incapacity incompetence and/or bias.
2. Delay.
3.External pressure or reasonable apprehension of external pressure.
5.Complete failure to consider or deal with material evidence of numerous witnesses.”
This judgment concerns those grounds of the liability appeal.
On 5 September 2000, the sixth day of argument in the liability appeal, Mr Walker SC, counsel for the defendants, announced that his clients accepted that Bruce J’s reasons for judgment in the proceedings were inadequate and that there ought to be consequential relief accordingly. That concession made it unnecessary for the Court to consider further any of the grounds of appeal in the liability appeal except to the extent that the likelihood of their success went to the question of how the costs of the appeal should be borne. The oral submissions up to the time that Mr Walker made his announcement were directed principally to grounds 5 and 2 but also to other grounds to a lesser extent. As a result of Mr Walker’s announcement, there were left for argument questions about what relief should be granted and what orders should be made on the liability appeal and the hearing of the limitation appeals.
After hearing argument on these matters, on 8 September 2000 the Court made the following orders:
“1.Appeals allowed against the judgment and orders of Justice Bruce of 22 February 1999 in favour of the defendants in each of the nine actions the subject of those appeals;
2. Set aside the judgment and orders;
3. In each of the nine actions order a new trial;
4.If required leave to the defendants to appeal from the judgment of Justice Bruce of 22 February 1999 and his Honour’s orders of 4 March 1999 extending the limitation periods for the plaintiffs’ causes of action under the Limitation Act 1969;
5.Appeals against the judgment and orders allowed;
6.Set aside the judgment and orders extending the limitation periods;
7.Order new trials of the plaintiffs’ applications to extend the limitations periods;
8. All questions of costs reserved;
9. Reasons to be given later.
The Court imposes no conditions on and gives no directions about the conduct of the new trials.”
BRUCE J’S JUDGMENT IN THE LIABILITY PROCEEDINGS
Despite the defendants’ concession in the liability appeal, it is necessary to outline as briefly as possible the contents of Bruce J’s judgment in the liability proceedings.
The judgment was divided into six numbered parts each of which contained sub-headings. These six parts were:
1.“INTRODUCTION” (43 pages). It included a sub-heading “SUMMARY OF PLAINTIFFS’ CASE”;
2.“PELVIC INFLAMMATORY DISEASE (PID)” (22 pages);
3. “CAUSATION” (33 pages);
4. “PROBABILITY OF CAUSATION” (146 pages). It included three sub-headings, “4.1 Epidemiology”, “4.2 Scientific Analysis”, and “4.3 Clinical Observations”;
5. “WARNINGS” (1 page);
6. “CONCLUSION” (2 pages).
I shall refer to these parts as “Part 1”, “Part 2” and so on.
In all, Bruce J’s judgment covered 247 pages, one of which was numbered but blank. By far the greater part consisted of transcriptions from the written submissions of the plaintiffs and the defendants. The plaintiffs’ written submissions included “Summary of Plaintiffs’ Case”, “Plaintiffs’ Submissions” and “Plaintiffs’ Closing Address”.
PART 1: “INTRODUCTION”
At the beginning of this part, Bruce J described the use of IUDs and how they were developed and marketed.
Bruce J explained how the nine plaintiffs were selected. Some of the nine were parous, that is to say they had already borne children at the time they used the Cu-7. Some had documented string retractions where the polypropylene string attached to the IUD retracted from the vagina into the uterus after the device had been inserted. Some plaintiffs had an ectopic pregnancy or pregnancies. One had a septic abortion. All but one suffered either complete infertility or impaired fertility.
Bruce J said:
“The plaintiffs’ case was in essence that use of the devices caused the plaintiffs to contract Pelvic Inflammatory Disease (PID) causing damage to their reproductive organs and thus either permanent or partial infertility and, in some instances, damage to the fallopian tubes resulting in ectopic pregnancies.
They submitted that the use of the devices put the users at greater risk of the introduction of infection into the uterine cavity or the fallopian tubes or to the ovaries than was the risk to non-users of the devices.
The plaintiffs claimed exemplary damages on the basis that the defendants acted in knowing and contumelious disregard of their rights, health and welfare.
The questions to be determined are:
1.Did the plaintiffs contract PID?
2.If so, was use of the defendants’ products causally connected with the contraction of PID by the plaintiffs?
3.If so, how were the defendants’ products causally connected?
4.Did that connection or connections or any conduct of the defendants or any of them constitute a breach or breaches of the duty of care owed by the defendants to the plaintiffs?
5.If there was a breach, did the defendants or any of them act in knowing and contumelious disregard of the plaintiffs’ rights, health and welfare?”
As has been seen, Bruce J had answered the first of the questions posed in the affirmative.
Bruce J said that, because of the quality and complexity of the evidence, he informed the parties during the hearing that the issues which would be determined were:
“1.Those properly raised by the pleadings and in accordance with the particulars provided, and
2.Those which were the explicit subject of submissions by the parties.”
Bruce J also told the parties that the only evidence which would be considered would be that evidence which was explicitly referred to in the submissions. No doubt the three linear metres of folders was the parties’ response.
Bruce J said that with the judgment were the following schedules:
“Schedule IA chronological list of relevant facts, documents and publications.
The chronology does not include the facts relevant to each individual plaintiff except for the dates of insertion of the defendants’ devices.
Schedule IIOverview of Plaintiffs’ Pleadings - Common Law Negligence - Gravigard (Cu-7) prepared by the defendants.
Schedule III Overview of Common Law Pleadings:
- Design/Manufacture
- Clinical Trials
- Marketingprepared by the defendants.”
Under the sub-heading “SUMMARY OF PLAINTIFFS’ CASE”, Bruce J said that the two pillars of the plaintiffs’ cases were based on negligence. They were failure to warn and defective design. The judgment continued:
“1. Failure to warn
The plaintiffs’ case on this basis is that
1.1A woman was placed at greater risk of contracting PID if she used an IUD including a Cu-7.
1.2 That greater risk was known to the defendants.
1.3The defendants failed to warn:
1.3.1 the plaintiffs; or
1.3.2 the plaintiffs’ doctors.
The threshold question in determining liability on this count is whether a woman was placed at greater risk of contracting PID if she used a Cu-7. The plaintiffs submitted that the affirmative of this question was established by:
1.Epidemiological evidence.
2.The scientific case as to the role of the IUD and its design defects in increasing the risk of PID.
3.The causes of increased risk of PID as explained from clinical expertise.
2. Defective Design
The plaintiffs allege that the Cu-7 had the following defects of which the manufacturer was aware but which it failed to rectify:
2.1 Fraying of the tailstring.
2.2‘Memory’ of the tailstring which caused it to retract into the uterus.
2.3 The inserter tube had the string on the outside of the tube.”
The defendants stressed that Bruce J stated that the threshold question in the failure to warn case was whether “a woman” was placed at greater risk of contracting PID if she used a Cu-7. This suggested, accurately it was said, a generic case rather than a case concerned with the experiences or symptoms of the particular plaintiffs. The defendants submitted that this justified Bruce J’s failure to deal with or even mention the evidence of each plaintiff’s clinical history.
Part 1 of the judgment proceeded immediately to heading 2.1 as follows:
“2.1 Fraying of the tailstring
This was said to have materially increased the risk of injury from ascending infection by:
(i)fraying creating rough surfaces thereby increasing the area to which bacteria could adhere;
(ii) bacteria prefer rough surfaces;
(iii) frayed surfaces allowed more bacteria to adhere;
(iv) more bacteria could colonise the frayed tailstring;
(v)the frayed surface provided a locus for infectious agents which can affect the uterus.”
The statement in 2.1 of the fraying case under defective design was of material increase in risk from ascended infection.
Bruce J next copied, without acknowledging the source, paragraphs 17 to 52 of the written summary of the plaintiffs’ case. Some insubstantial changes were made in the text. This material was later duplicated in Part 4.2 of the judgment dealing with “The Scientific Analysis”. The reproduction of the following paragraphs is illustrative.
Paragraph 17 was reproduced as:
“The plaintiffs’ evidence called to support the case pleaded that the tailstring had a design defect by virtue of being made of polypropylene and subjected to tension in manufacture making it prone to fray.”
This was a mistranscription. The summary itself started: “The plaintiffs called evidence”, which makes sense of it. However, Bruce J acknowledged that such evidence was called.
Bruce J reproduced without comment part of paragraph 22 of the summary of the plaintiffs’ case as follows:
“There is no dispute between the parties as to the fraying being caused by the way in which the tailstrings were manufactured. Professor Robertson gave evidence that application of tension (or drawing) to the Cu-7 tailstring aligned polymer chains along the length of the tailstring. This had the effect of strengthening the tailstring along its length at the cost of weakening lateral bonds within the tailstring. The result was that the tailstring would withstand a greater pull before breaking but became prone to fray. His evidence applies to the entirety of the length of the tailstring.”
As reproduced in the judgment this looks like a finding.
The judgment continued, reproducing more of paragraph 22 as follows:
“It was submitted that the evidence of Professor Fives-Taylor and Professor Robertson and the letter from the National Biological Standards Laboratory support the finding that Cu-7 tailstrings, being made of highly drawn polypropylene, frayed throughout their length.”
After this paragraph, his Honour said: “I accept that this was so.” Bruce J was satisfied that the Cu-7 tailstrings were prone to fray in use.
The reproduction of paragraph 23 is significant. Bruce J said:
“The defendants argued that fraying by itself was solely an aesthetic problem without medical consequences. The plaintiffs submitted that a frayed tailstring will have a larger and rougher surface area than a non-fraying tailstring and will thereby attract bacterial adhesion and colonisation, increasing the risk of pelvic inflammatory disease.”
His Honour acknowledged this point of dispute.
The summary of the plaintiffs’ case, which Bruce J copied, discussed desquamation, which is the body’s primary defence against infection by micro-organisms, and the consequence of the adherence of a micro-organism to a surface, such as that of a Cu-7 or Mini which cannot desquamate. Micro-organisms which have adhered to an IUD could exude a substance which formed a “slime” layer over the IUD. This formed a biofilm which rapidly covered the whole of the surface of the device. Professor Ellner gave evidence that micro-organisms can and do colonise the surface and interior of this biofilm. Bruce J reproduced the summary of the plaintiffs’ case in which the plaintiffs submitted “that because of the fibrillation which causes frayed and rough surfaces, bacteria are better able to adhere to the Cu-7 tailstring than to other tailstrings. This was said to be supported by the evidence of Professor Katz.” Bruce J inserted the words “said to be” in the last sentence.
His Honour next copied paras 27, 28, 29 and 30 of the summary of the plaintiffs’ case which referred to the evidence of Professors Katz, Kaplan, Robertson and Fives-Taylor about the adherence of bacteria to rough surfaces and concentrations of the biofilm:
“Professor Fives-Taylor undertook experiments which indicated that up to 10 times as many bacteria adhered to frayed parts of the Cu-7 tailstring as to smooth parts. The defendants accept that bacteria can adhere to IUD tailstrings.
Professor Fives-Taylor conducted experiments to measure bacterial adhesion to various tailstrings and polymers. She measured specific adherence of radioactively ‘tagged’ bacteria to unprocessed beads of polyethylene, polypropylene and co-polymer. While some bacterial species adhered better to one material and some to another, there was little or no overall preference shown by various bacterial species for one over another. Six of ten bacterial species tested adhered better to polyethylene and four adhered better to polypropylene.
She then measured specific adherence of bacteria to tailstrings of IUDs. The results demonstrated much greater adhesion to the polypropylene tailstring of the Cu-7 over the tailstrings of other devices. This held true across bacterial species. Twelve of the thirteen bacterial species tested adhered better to polypropylene in tailstring form. There was no result for the thirteenth.
Professor Fives-Taylor concluded that it was the processing of the material, rather than the choice of polypropylene itself, which accounted for the greater adherence of bacteria to Cu-7 tailstrings over the tailstrings of other materials.”
It is unclear whether any of these unmarked quotations were intended to be findings.
From the summary of the plaintiffs’ case, reference was made to Professor Kaplan’s criticisms of some of the techniques used by Professor Fives-Taylor in her bacterial adherence experiments. This section finished:
“Professor Kaplan did not point to any scientific literature which suggested that Professor Fives-Taylor’s experiments should not be given weight.”
Again it is unclear whether Bruce J accepted the validity of Professor Fives-Taylor’s experiments.
Bruce J continued to quote the summary of the plaintiffs’ case which on this question ended:
“the defendants concede that bacteria adhere to tailstrings so there is nothing unlikely in Professor Fives-Taylor’s results.”
The next heading in Part 1 of the judgment was “Medical Risks Due To Defects”, again taken from the summary of the plaintiffs’ case. This was directed to the defendants’ argument “that, even if there are medical risks due to defects, these nevertheless have no clinical implications”. Reference was made to Professor Kaplan, one of the defendants’ witnesses, who was of the view that “because the epidemiological data cleared IUDs from involvement in infections, IUDs were necessarily different from other biomedical devices”. Bruce J said, copying para 34 of the summary of the plaintiffs’ case:
“Professor Kaplan accepted that cells might detach from the biofilm of an IUD in situ and, in a host whose defences are lowered sufficiently, might cause infection. However he suggested that the probability would be that the large numbers of pathogens constantly accessing the upper genital tract would cause PID rather than pathogens detaching from the biofilm-covered IUD.”
Bruce J continued by saying the plaintiffs’ submitted that this opinion, “was not based on [Professor Kaplan’s] expertise in microbiology but rested on his understanding of the epidemiology as exonerating the Cu-7. He agreed that his opinions were not informed by any expertise as an epidemiologist….. although he has read the literature and formed opinions. If the epidemiological prop to his argument is removed, it was submitted that his concession as to the microbiological point goes a long way to support the plaintiffs’ case.”
Bruce J said, reproducing paras 36 and 37 of the summary of the plaintiffs’ case:
“Professor Ellner expressed a quite different view as to the importance of pathogens leaving the biofilm. He expressed the view (as did Professor Katz) that the biofilm protects bacteria from the host immune system and antibiotics, allowing pathogens to survive in the upper genital tract, an area of the body where they would ordinarily be eliminated by the immune system. His evidence was that the biofilm on an IUD can concentrate nutrients, enabling the bacteria to multiply with the biofilm. He stated that the biofilm covered Cu-7 forms a ‘nidus’ or infective reservoir from which micro-organisms can emerge to infect the host. His evidence was that whether the bacterial colonisation of the Cu-7 results in infection or not depends upon many factors involving the state of host defences and the numbers and virulence of the micro-organisms. However the role of the fraying as a design defect was to provide a reservoir of pathogens able to infect the uterus.
The danger of frayed strings was said to be given support by Dr Stewart who declared that frayed strings were ‘medically unacceptable’ (Exhibit P486). A number of Searle documents refer to the dangers of infection from frayed tailstrings. The plaintiffs submitted that the evidence of Professor Ellner, supported by the plaintiffs’ and defendants’ clinicians, (who agreed that they would remove the Cu-7 in the event of infection), should be preferred to that of Professor Kaplan.”
Bruce J did not discuss or resolve the differences exposed by the evidence to which he referred. He simply copied out the submissions.
Under the heading “Colonisation”, Bruce J copied paragraphs from the summary of the plaintiffs’ case which he later duplicated in Part 4.2 under the heading “ ‘Ascension’ up the tailstring”. Paragraph 40 of the summary of the plaintiffs’ case, which Bruce J copied, acknowledged that an issue between the parties “was the extent, if any, to which the tailstring of the Cu-7 could assist a potential pathogen to ‘ascend’. One mechanism pleaded in relation to this is the contamination of the device with bacteria from the vagina or lower cervix upon insertion. There is no dispute that this occurs. Another mechanism pleaded is the retraction of the tailstring into the uterus.” The summary of the plaintiffs’ case quoted next went on after “Leaving these mechanisms aside”, to deal with the rapid coating of the Cu-7 by a biofilm colonised by bacteria upon insertion into the body. Bruce J, copying part of para 41 of the summary of the plaintiffs’ case, said:
“In this sense it was submitted there is no real argument that the presence of the device has assisted in the establishment of micro-organisms in the upper genital tract. The question is whether they can do any harm.”
Again the copied summary of the plaintiffs’ case refers to the views of Professors Ellner, Katz, Fives-Taylor and Robertson on behalf of the plaintiffs which it was submitted should be preferred to those of Professor Kaplan on behalf of the defendants. For example, from para 42 of the summary of the plaintiffs’ case, which Bruce J copied:
“Professor Ellner gave evidence that biofilm confers a substantial number of advantages upon bacteria which permit them to survive permanently in the upper genital tract. Professor Katz supported this evidence as did Professor Fives-Taylor.”
Paragraph 43 of the summary of the plaintiffs’ case, which was reproduced verbatim, acknowledged a disagreement between the parties as to the mechanisms which might allow bacteria to move into the upper genital tract. This disagreement was described in the submissions set out in the judgment. The plaintiffs submitted “that the evidence of Professors Ellner, Katz, Robertson and Coughlin that the Cu-7 and Mini tailstring can facilitate the transport of micro-organisms into the upper genital tract should be accepted.” Bruce J did not deal with this submission.
The next section of Part 1 was headed “Design Criteria”. The plaintiffs claimed that the defendants’ negligent actions included the defendants’ failure to apply applicable design criteria in the decision to use highly drawn polypropylene as the tailstring material. Again, Bruce J quoted the plaintiffs’ discussion of the evidence given by Professor Robertson for the plaintiffs and Dr Piziali for the defendants.
Next came a heading “2.2 ‘Memory’ of the tailstring which caused it to retract into the user’s uterus”. Bruce J said, again copying the summary of the plaintiffs’ case:
“This was said to materially increase the risk of injury from ascending infection by:
(i)string retraction into the uterus introducing more potential pathogens than otherwise would be introduced;
(ii)string retraction required additional instrumentation of the uterus to remove device the device [sic] which instrumentation increased risk of introducing infection; [This was a mistranscription of the summary. Neither made sense].
(iii)the defendants admitted that uterine instrumentation increases the risk of introducing infection.
Following the successful insertion of a Cu-7 in the uterus, the tailstring ran from the bottom of the Cu-7 in the uterus through the cervix and into the vagina to provide the user or her doctor with an easy method of checking that the device was still in place and to facilitate the removal of the device.
The Cu-7 is shaped like a figure 7 with a small rounded cap which fused the horizontal arm and the curved vertical stem together. Copper wire is wound around the vertical stem. The polypropylene tailstring is attached to the lower end of the vertical stem. When the device is packaged, the Copper 7 stem sits in the inserter tube. The tailstring joins at the base of the stem (inside the inserter tube), and turns to pass up the tube beside the device before emerging from the top of the inserter. It then loops through 180 degrees to run down the outside of the inserter tube. This can be seen clearly in Exhibit P3, a box of packaged Copper 7s.
The plaintiffs alleged in each case that in its packaged configuration the tailstring was looped out of the top of the inserter tube rather than run down the inside of the inserter tube, such loop resulting in a string ‘memory’ which caused the tailstring to have a propensity to retract into the uterus resulting in:
(A)the tailstring transferring bacteria and/or other infectious organisms from the vagina into the uterus;
(B)the need for instrumentation of the uterus; and an increased risk of Pelvic Inflammatory Disease (‘PID’).”
(Bruce J had adopted the acronym earlier in his judgment).
Bruce J observed, again copying the summary of the plaintiffs’ case, that the plaintiffs pleaded as particulars of the exemplary damages sought that the defendants were aware that the Cu-7 tailstring had a tendency to retract into the uterus increasing the risk but chose not to remedy the defect. The defendants did not dispute that retraction of the Cu-7 tailstring into the uterus occurred. They said that this retraction phenomenon was unrelated to the design of the Cu-7, and, in any event, did not increase the risk of upper genital tract infection.
Again, the judgment consisted of quotation, from the plaintiffs’ case, of the plaintiffs’ submissions. These copied submissions referred to the evidence of Dr O’Brien for the plaintiffs and Dr Piziali for the defendants. Part of the reproduction of the plaintiffs’ case was as follows:
“The defendants relied upon [Dr Piziali’s] evidence to counterbalance the exhibits tendered by the plaintiffs many of which are Searle documents referring to the effect that the special characteristic of the polypropylene (the ‘memory’) used in the tailstring accounted for the retraction phenomenon.”
His Honour substituted the word “referring” for the words “containing admissions” in the text of the plaintiffs’ case. The defendants’ case, that the Searle employees, who believed there was a memory effect inherent in the polypropylene, were wrong because they did not have sufficient expertise, was countered by statements to similar effect from Battelle, expert design engineers employed by Searle to assist in solving the retraction problem. Similar experiences were reported by doctors using the Cu-7.
Bruce J continued, copying from the summary of the plaintiffs’ case, by referring to the evidence they relied on from the Searle documents and from Professors Robertson and Katz to establish that the polypropylene used by Searle in the tailstring had a propensity to retract. Again, copying the submissions, Bruce J said “The second dispute about retraction is whether it increased the risk of PID”. Reference is made to the evidence of various witnesses including four of the plaintiffs. This is all simply copied from the summary of the plaintiffs’ case. From that source, Bruce J summarised the plaintiffs’ submissions as follows:
“(a)the evidence of Professors Ellner, Robertson, Katz and Fraser as to the direct contamination of the uterus by string retraction combined with
(b) the Searle documents,
(c)the consensus as to the risk of instrumentation (necessitated by the retraction in at least three of the lead cases) and
(d)the concerns as to the potential of the frayed tailstring to pose a risk of infection independently of fraying to support a finding that the retraction of the tailstring provided a means whereby bacteria could be carried from the vagina into the uterus, thereby increasing the risk of PID for users of the Cu-7.”
Bruce J did not deal with these submissions.
Part 1 of the judgment continued under the following heading:
“2.3 The design of the inserter of the Cu-7 had the string on the outside of the inserter tube
As a result of this, the string trailed through the bacteria laden parts of the lower genital tract and trans-cervically introduced potential pathogens into the uterus.”
As Bruce J reproduced from the summary of the plaintiffs’ case, each plaintiff submitted that two or more of the alleged design defects increased the risk of injury. The judgment continued:
“The plaintiffs submitted that the general matters which prove liability on the part of the defendants are:
(a)the use of the Cu-7 increased the risk of PID and its sequelae;
(b)the defendants were aware of the epidemiological data which proved or provided compelling evidence that use of IUDs in general and of the Cu-7 in particular caused an increased risk;
(c)the defendants knew or ought to have known that the design defects caused or were likely to cause an increased risk;
(d)the defendants, notwithstanding their knowledge as set out in (b) and (c) above, negligently failed (i) to warn of the increased risk; and (ii) to remedy the defects;
(e)the plaintiffs suffered injury, namely PID and its sequelae, and for Gentle a septic abortion, as a result of the defects and/or the increased risks;
(f)the plaintiffs would not have suffered the injury had each been warned of the increased risks;
(g)the plaintiffs were not warned of the increased risks.
It was submitted that each of the three alleged design defects dealt with above was a material contribution to the risk of injury and not ‘de minimis’ because:
1.(i) the defendants’ own behaviour revealed its recognition that the problem (ie the added risk) was not de minimis.
(ii)contemporary medical opinion: eg Dr Hatcher, Dr Tyrer of the Planned Parenthood Federation of America, the Food and Drug Administration, the Australian National Biological Standards Laboratory was of that view.
(iii)epidemiological data showed that users of Cu-7 were at an increased risk of PID and its sequelae.
(iv)the foreign body effect potentiates and prolongs the risk of infection from additional bacteria introduced because of design defects.
2. No alternative causes were proved by defendants.
The plaintiffs submitted that each of the three defects were negligently incorporated in the design of the Cu-7 by the defendants and that independently and jointly they made a material contribution to the risk of injury to each plaintiff.”
The judgment next turned to consider the cause of PID as identified from clinical expertise and, in particular, the defendants’ attempts to prove that it must have been a sexually transmitted disease not an IUD which caused any episode of PID suffered by the plaintiffs. Mrs Denzin was the exception to this attempt. Quoting from the summary of the plaintiffs’ case Bruce J set out the arguments and concluded Part 1 of the judgment, “INTRODUCTION”, as follows:
“The plaintiffs submitted that the opinions of the plaintiffs’ medical experts as to the occurrence of PID during Cu-7 use (Gravigard and Mini-Gravigard) and the role of the IUD in causing the PID should be preferred to those of the defendants’ medical experts who were, it was submitted, not able to offer any convincing alternative explanation for the PID suffered by the plaintiffs. It was also submitted that the expert opinions of the plaintiffs’ medical witnesses as to the causal role of the Cu-7 in PID were consistent with and supported by the epidemiological data, the medical principles relating to infections and the foreign body effect, and their own clinical experience.”
According to this paragraph the thrust of the plaintiffs’ case was based on the medical expert evidence about the occurrence of PID during Cu-7 use supported by epidemiological data. These submissions were never dealt with. Part 1 was little more than a narrative of submissions.
PART 2: “PELVIC INFLAMMATORY DISEASE (PID)”
The first two pages of Part 2 were devoted to a description of the female reproductive system above the vagina. The uterus, the fallopian tubes and the ovaries were described. The judgment next picked up the plaintiffs’ submissions on PID. Again, these were copied without quotation or acknowledgment. Bruce J included definitions of terms and also interspersed at the beginning material taken particularly from the evidence of Professor Eschenbach.
Under the sub-heading “The Cause of PID” three topics were mentioned:
The body’s defence mechanism
Effects of PID
Diagnosis of PID
For the most part this involved copying the plaintiffs’ submissions with some minor additions apparently from other sources. Under the sub-heading “Effects of PID” two tables were copied from the plaintiffs’ submissions.
A similar pattern was adopted under the sub-heading “Diagnosis of PID”. Part 2 of the judgment concluded:
“A question to be determined in each of the nine cases is whether the plaintiffs suffered PID in association with Cu-7 use. The plaintiffs submitted that in eight of the cases ….. the existence of PID has been confirmed by objective tests so that the task of the expert witnesses was to identify whether or not there were signs or symptoms of PID in association with Cu-7 use.
They submit that the presence of tubal damage in the absence of any alternative cause supports the finding that it was caused by PID.”
Bruce J acknowledged a case based on expert identification of signs and symptoms. But, to this point of the judgment, little more had been done than repeat the written submissions.
PART 3: “CAUSATION”
The first six lines of Part 3 posed as the question to be answered “whether the Cu-7 was causative of the PID in the particular case”. Bruce J stated and then re-worded the legal principle upon which the plaintiffs said their case was based. He next formulated counsel’s oral submissions in three propositions:
“The first proposition that if you use a Copper 7 ‘you are more likely to get PID than if you don’t’ is a factual question to which I shall come later.
The next proposition is that if the first proposition is established and the woman has suffered PID, that in itself (subject to the third proposition) is enough to establish causation in the legal sense.
The third proposition was that it is open to the defendant to attempt to prove that irrespective of the increased risk of using the IUD, the injury was suffered because of some other entirely different event.”
Bruce J quoted extensively from judgments in seven decisions. Over nineteen pages came from the decision of this Court in Bendix-Mintex Pty Limited v Barnes (1997) 42 NSWLR 307. After these references, Bruce J said at the end of this part:
“In my view the law of New South Wales is as was stated by the learned President in Bendix. It is not, as he says, for an intermediate Court of Appeal to change it let alone for a trial judge such as myself.
Whatever may be one’s views of the social desirability of the High Court and Parliament of [sic] changing the law to in effect shift the burden of proof to a defendant of showing that his negligent actions did not cause injury to the plaintiff where the plaintiff has shown that the actions of the defendant increased the risk of the plaintiff sustaining the injury which was sustained, it is not open to me to decide this case on that basis.
Simply establishing that a causal connection between the actions of the defendant and the injury to the plaintiff is possible does not justify a finding of causation unless the evidence justifies an inference of probable connection.
Accordingly I do not accept the submission on behalf of the plaintiffs in respect to the proof of causation. In order to succeed the plaintiffs must, according to the law of New South Wales, establish that the or a probable cause of their injury was the negligence of the defendants.”
On 2 September 1998, after Bruce J had reserved judgment, the High Court gave judgment in Chappel v Hart (1998) 195 CLR 232. His Honour asked the parties to file further submissions. The parties’ submissions dealt in detail with the law of causation as explained by the High Court in that case. Bruce J referred neither to the submissions nor to the High Court decision.
PART 4: “PROBABILITY OF CAUSATION”
After a numbered blank page Part 4 began:
“The evidence of causation relied on by the plaintiffs as pointing to the conclusion that Cu-7 use caused or materially contributed to the acquisition of PID and its sequelae and to septic abortion was as follows:
4.1 Epidemiology
4.2 Scientific analysis
4.3 Clinical observation
The plaintiffs’ case is that use of IUDs ‘enhanced’ or ‘materially contributed’ to PID.”
As will be seen the submissions under Part 4.2 were disposed of in six lines. Part 4.3 was disposed of in three paragraphs.
Part 4.1: “Epidemiology”
At the beginning of Part 4.1 Bruce J said:
“The threshold question is whether a user of a Cu-7 was placed at a greater risk of PID than if she had not used a device. The parties were diametrically opposed on the answer to this question.
The plaintiffs assert that there was an increased risk. The defendants assert that the only increased risk involved was a risk associated with the process of insertion of the device into the uterus (an iatrogenic risk).
The plaintiffs seek to establish the existence of an increased risk by the use of epidemiological evidence. They submitted that throughout the decade from 1975 when the first insertion of an IUD relevant to these proceedings occurred ‘there was a drum beat of concern in the medical literature about the increased risk from IUD use, PID and its sequelae’.
The defendants conceded that virtually all of the numerous case studies published reported a statistical association between PID and the use of an IUD but submitted that there are ‘cogent reasons why these studies, when properly interpreted, cannot establish a causal link between the use of the Gravigard/Mini and PID with its sequelae.’ ”
Bruce J described what epidemiology is and referred to two methods of statistically determining cause. He quoted the defendants’ submissions on selection bias, assessment or data bias and chance. He referred to the opinions of experts notably, Professor Newton and Professor Daling about bias and explained a number of relevant epidemiological terms. Bruce J referred to “two significant reviews of the literature relevant to the issue of causal connection between IUD use and PID and its sequelae including ectopic pregnancy”. Having stated the conclusions reached in each of those reviews, which came from the plaintiffs’ closing address, together with some additional reviews, Bruce J said:
“The plaintiffs sought a finding that at the time of each IUD insertion relied upon by the plaintiffs, Searle was in possession of strong evidence from epidemiological studies which pointed to a causal association between IUD use and PID. The association, as revealed by the studies referred to above, was so strong and consistent that Searle was under a legal obligation to act on the basis of that causal association.
The plaintiffs submitted that if this finding is made and if subsequent scientific research has not reviewed the conclusion in so far as it applies to Cu-7 then their case relating to a failure to warn is made out.
The defendants submitted that later epidemiology was able to isolate the risk associated with Cu-7 itself and established that there was no increased rate of PID associated with Cu-7 use. The defendants further submitted that there was no increased risk among women in stable monogamous relationships.
The defendants dealt with the papers referred to in the two overview papers to attempt to demonstrate that they could not be relied upon to support the conclusion contended for by the plaintiffs.
I shall deal with each of the papers in the order in which they appear in the reports.”
There followed over the next seventy-five pages summaries of the reports taken entirely from the defendants’ submissions apart from two relatively short extracts from the plaintiffs’ closing address. There were occasional omissions and insertions. At the conclusion of this material, Bruce J said:
“The plaintiffs submitted that the studies referred to and the evidence of Professor Daling lead to the conclusion that the broad sweep of epidemiological evidence leads to the conclusion that use of the Cu-7 increases the risk of PID to the users.
The epidemiological material relied upon included many studies which do not include the Cu-7 and which relate to populations which are significantly different in a sociological sense to any of the plaintiffs.
The plaintiffs seek to draw a conclusion from this disparate material that use of the Cu-7 by the plaintiffs in these proceedings increased the risk of their contracting PID leading to a conclusion of probable causation of the injuries which they sustained.
The defendants on the other hand submitted that it was proper to analyse each study and to ascertain how they fitted into the pattern of knowledge after proper allowance was made for weaknesses which appeared in their methodology. In my view this is the correct approach.”
Bruce J again quoted some short paragraphs from the defendants’ submissions and said:
“The defendants also submitted that the analyses of the material shows that women in the category of the plaintiffs do not have any statistically significantly higher risk of contracting PID when using copper IUDs.
In addition to lengthy analysis and criticism of the twenty-five publications referred to earlier the defendants relied upon extensive state-of-the-art literature supporting the use of IUDs.
I accept the evidence of Professor Roy as to the risk of infection based on his own experience and on the WHO Report (Farley 1992) that the risk was greatest for the first twenty days after insertion and that thereafter the rate of infection closely paralleled the background rate of sexually transmitted organisms of the population under study.
Professor Roy also drew attention to the 1983 Women’s Health Study which analysed different degrees of risk of PID with specific types of IUDs (Lee et al, 1983) and concluded that there were differences.
Professor Roy also pointed out that earlier studies had compared IUD users with women who used contraceptives which protected against PID and that this comparison falsely elevated the risk [of] PID for IUD users. Also earlier studies had in many cases included users of Dalkon Shield IUDs which increased the rate of infection shown.
I do not accept Professor Daling’s 1992 recalculation of her 1985 report as displacing the opinions of Professor Roy which I accept.
It follows that with all its manifest imperfection the epidemiological evidence does not establish in my view that there is any statistically significant increase in risk of contracting PID for users of the Cu-7 although there is an increased risk in the first twenty days after insertion which risk is associated with the insertion procedure.
In the light of this finding the findings sought by the plaintiffs on pages 181 and 182 are not relevant as the information which was then available was not in my view reflective of the true situation.”
The page references are not those in the judgment. They may be references to what appears in para 59 above which were on pages 184 and 185 of the judgment.
This short statement of conclusions does no justice to the detail and range of expert epidemiological evidence tendered by the parties. Moreover, as Bruce J had acknowledged early in the judgment, the epidemiological evidence was only one of the three ways in which the plaintiffs sought to answer the threshold question for determining liability by showing that a woman was placed at greater risk of contracting PID if she used a Cu-7. The plaintiffs also relied on a scientific case and clinical expertise.
In their written submissions to this Court the plaintiffs said that fifty-two witnesses, mostly experts and/or treating doctors, gave written and oral evidence at the trial and all except one were cross-examined. Written affidavits and witness statements were tendered on behalf of the plaintiffs in respect of an additional twenty-three witnesses who were not required for cross-examination. Nine of these were medical practitioners. The plaintiffs submitted that of the fifty-two witnesses who gave oral evidence in the liability proceedings, Bruce J did not refer to (other than in passing), analyse or make findings in respect of any of the oral and written evidence of forty-four witnesses concerning
(a) individual causation issues in the cases of one or more of the nine plaintiffs (thirty-eight witnesses); and/or
(b) the issues of liability in respect of the alleged negligent failure adequately to test the Cu-7 devices in clinical trials (nine witnesses, including three, part of the thirty-eight referred to before).
None of the evidence of the twenty-three witnesses not required for cross-examination was considered in the judgment.
In Flannery v Halifax Estate Agencies Limited [2000] 1 WLR 377, a decision of the English Court of Appeal, a firm of surveyors was sued for negligence. At 379 Henry LJ, who gave the judgment of the Court, said that the trial judge had summarised the history of the litigation at some length. Henry LJ described what followed as:
“a bare summary of the expert evidence given on behalf of each party, being introduced with the observation that the plaintiffs’ evidence was ‘entirely different’ from that called by the defendants. Ten lines or thereabouts is spent on the plaintiffs’ case with the bare assertion of the conclusion ‘the property had suffered from significant structural movement’ without any supporting argument or detail beyond saying ‘They drew my attention to a number of features concerning the property which they said confirmed their opinion ….’
Then just over a page is spent on the defendants’ case, with the conclusions from Mr Atkinson’s report of 4 March 1997 being expressly quoted. Again, assertion and not supporting evidence or argument is there set out.”
The conclusion of the trial judge in that case was expressed in a paragraph which opened with the hallowed statement (at 380):
“I have had the advantage not only of hearing the various witnesses give evidence but also of seeing the way in which they reacted to the questions that they were asked. Having done so, I prefer the expert evidence that was given for the defendants to that which was given for the plaintiffs. I find, on the balance of probabilities, that the property was described reasonably accurately by Haining in his report and that the opinion expressed by Mr Atkinson is correct.”
There was a little more elaboration in the following dozen or so lines of the trial Judge’s reasoning process.
Henry LJ referred to Eckersley v Binnie (1988) 18 Con LR 1 at 77-8 where Bingham LJ said that: “a coherent reasoned opinion expressed by a suitably qualified expert should be the subject of a coherent reasoned rebuttal, unless it can be discounted for other good reasons”. In Flannery at 382 Henry LJ said:
“where the dispute involves something in the nature of an intellectual exchange, with reasons and analysis advanced on either side, the judge must enter into the issues canvassed before him and explain why he prefers one case over the other. This is likely to apply particularly in litigation where as here there is disputed expert evidence ….”
With due respect I entirely agree.
In the present case on those parts of the judgment to which I have so far referred, Bruce J did little more over nearly two hundred pages than recite or copy out submissions by the parties and state conclusions based, so it was said, on the acceptance of the evidence of Professor Roy. That evidence was nowhere earlier referred to. Bruce J did not in any sense enter into the issues, which were canvassed before him, or explain why he preferred one case over the other.
At 382, Henry LJ quoted the “classic statement” from Lord Thankerton’s speech in Watt or Thomas v Thomas [1947] AC 484 at 488 dealing with the occasion when a Court of Appeal may intervene.
“The appellate court, either because the reasons given by the trial judge are not satisfactory, or because it unmistakably so appears from the evidence, may be satisfied that he has not taken proper advantage of his having seen and heard the witnesses, and the matter will then become at large for the appellate court.”
Ground 5 of the plaintiffs’ grounds of appeal was that there was a complete failure to consider or deal with material evidence of numerous witnesses.
Next, still in Part 4.1, was a heading “Ectopic Pregnancy”. Apart from giving the meaning of the expression, again Bruce J copied into his judgment parts of the plaintiffs’ closing address together with tables followed by parts of the defendants’ submissions. All this covered some fifteen pages including the defendants’ review of medical literature under nine numbered headings. The judgment continued:
“These factors have varying degrees of impact on the rates of ectopic pregnancies. It is not necessary to deal with the other [sic] to indicate that they may be factors which increase the apparent rate in association with IUDs.
Experts called on behalf of the defendants expressed the opinion that past use of a Cu-7 did not result in an increased risk of ectopic pregnancy.
Professor Grimes T5884-5
Professor Roy T6099-6101
Dr Keeping T6389-6390
Professor Newton T6643-6645
Professor Fraser T6750-6751 and 7691-6794
10. Basuki et al 1994 (Ex P209, Tab 1)
This study showed a statistically significant increased risk for women with 36 or more months use. Any shorter duration of use did not produce a statistically significant result. The study did not determine the type of IUD used. There was also a very small number of relevant articles which gives an extremely wide confidence interval.
In my view the material relied upon by the plaintiffs and the evidence by Professor Daling as to the effect of past use of Cu-7 on ectopic pregnancies does not establish that there was in fact any statistically significant increase in the risk of ectopic pregnancies as a result of past use of Cu-7. An analysis of the literature not show [sic] any support basis for the proposition propounded by the defendants [sic plaintiffs].
I accept the evidence of Grimes, Roy, Keeping, Newton and Fraser referred to above and find that there was no increase in ectopic pregnancies as alleged by the plaintiffs.
I found Professor Daling’s selective assessments throughout her evidence unfairly pointing to IUD associated risk unsatisfactory and her general approach to the giving of her evidence is not to be ignored in the conclusions which I arrive at.
Further, in my view none of the material referred to led to the conclusion that the state-of-the-art while the Cu-7 was sold showed a view that use of a Cu-7 would increase the risk as alleged. Nor is there any basis for concluding that the defendants were aware of such an increase. The so-called Peddie Memorandum does not in my view disclose any such knowledge.”
All this reads as little more than assertion.
Bruce J next referred by name to three 1995 publications the plaintiffs relied on and said:
“In my view these three recent publications, when properly analysed, do not alter the conclusion which I have expressed above. The Mol and Xiong papers analyse previous data without what, in my view is necessary, namely excluding Dalkon Shield results and differentiating between types of IUDs. Parazzini is a small and inconclusive study.
The defendants drew attention to other risk factors for ectopic pregnancies including prior induced abortions, previous abdominal surgery including appendectomy, vaginal douching and maternal smoking.”
What the proper analysis was, was not revealed.
Part 4.2: “The Scientific Analysis”
Part 4.2 began:
“This topic was dealt with in detail in Part 3 of the plaintiffs’ submissions.
It was an attempt to demonstrate ways in which the IUD could be shown scientifically to cause the introduction of pathogens.
The matters dealt with under this heading are:
1. Tailstring
It was said that bacteria which are pathogenic if introduced into the upper genital tract are able to adhere to the polymer of which the Cu-7 tailstring was made and that as that polymer was prone to fray more bacteria could adhere to it than would otherwise be the case so that in the event that the tailstring retracted into the uterus pathogens were introduced. Secondly it was said that bacteria could adhere to the tailstring and colonise it. The bacteria could then spread along the tailstring thereby finding a means of entry into the upper genital tract.
In summary it was submitted that the Cu-7 may ‘cause’ the ingress of PID bacteria by
(a) retraction of the tailstring
(b) ‘ascension’ of the bacteria up the tailstring
(c) carriage upon insertion.
The defendants submitted that neither (a) nor (b) have been shown to increase the chance of upper genital tract infection. The defendants admitted that (c) was a possibility but submitted that in relation to Lee, Moylan, Orders, Ottaway and Robertson whose cases were opened as cases of insertion infection they did not suffer PID as a result of the insertion of their Cu-7s.
They further submitted that insertion infection was a matter of which all doctors were aware and was not a risk which rendered the Cu-7 defective so that there was no causal link rendering Searle liable for insertion infection.
Further it was submitted that there was no evidence of facts which elevated mere possibility to the requisite level of more likely than not.
2. Foreign body effect
It was said that the amount of bacteria required to cause infection in the upper genital tract varies depending upon such things as the virulence of the organism, the access it may have to vulnerable tissue liable to be infected and the immune system of the patient which may be affected by the woman’s health at the time.
It was also said that the presence of a plastic and copper device inside the uterus causes a reaction called the foreign body effect which dramatically reduces the amount of bacteria necessary to cause infection.
The defendants submitted that this did not achieve the status of an accepted hypothesis and should be rejected as inadequate to show or assist in showing a causal link.
Tailstring
As indicated in the introductory passage above the plaintiffs allege that PID bacteria may enter the uterus of a user of a Cu-7 by
(a) retraction of the tailstring
(b) ‘ascension’ up the tailstring
(c) by carriage on insertion
(a) Retraction of Tailstring
It was said that there was a tendency of polypropylene to resume its earlier configuration as string memory and when it happened it would draw the string up into the uterus introducing the likelihood of contamination by pathogens.
This allegation relates to Denzin, Gentle, Lee and Ottaway.”
About seven and a half pages followed in which Bruce J copied the summary of the plaintiffs’ case. His Honour said:
“The defendants do not dispute that retraction occurs but say that it is not due to any design defect or ‘memory’. (Dr Piziali, Ex D306 at para 112). Dr Piziali also demonstrated on a video the deformation of a Cu-7 tailstring. He expressed the view that it was impossible for the tailstring to retract because of memory.
I accept the evidence of Dr Piziali. In my view the plaintiffs have not established that retraction occurs because of ‘memory’ or any other design fault in the Cu-7.
Retraction does however occur as it does apparently with all tailed IUDs.”
The evidence of Dr Piziali about memory effect had been referred to twice in two identical quotations from the summary of the plaintiffs’ case. These references each occupied about twelve lines of the judgment.
Next, under a heading again taken from the summary of the plaintiffs’ case “(b) Increasing The [sic] risk of PID”, over two pages were copied from the summary of the plaintiffs’ case. Bruce J said:
“The defendants [sic] position is that tailstrings are a common element in IUD design to aid in location and removal. The defendants submitted that irrespective of the propositions put forward on behalf of the plaintiffs there was no evidence that users of tailed IUDs suffered a higher incidence of PID than did users of tail-less IUDs and relied on the following evidence:
Statement of Professor Newton; Ex D299 at paras 141-153.
Statement of Dr Piziali; Ex D306 at paras 24-41.
Statement of Professor Grimes; Ex D300 at paras 97-103.
The plaintiffs did not tender any published literature showing any difference in the incidence of PID between tailed and tail-less IUDs. Indeed the published science is to the contrary (eg Rivera 1993, Ex D321 at page 177).
Further the defendants submitted that there was no evidence that the tailstring on the Cu-7 retracted at any greater frequency than tailstrings on other IUDs. A survey of the literature by Drs Ebi and Piziali (Ex D362) showed that the Cu-7 retractions were less than for the other two makes of IUDs reported on.
In my view the evidence establishes that:
(1)Tailstrings of the Cu-7 did retract and assume their pre-insertion shape.
(2)There were many complaints of the retractions to the defendants.
(3)The defendants believed that the cause of the retractions was the ‘memory’ of the string.
(4)The defendants set about changing the tailstring for what was described as ‘safer’ polyethylene.
(5) The change was not implemented.
(6)The non-implementation was most probably because Searle was subject to law suits in the United States and did not wish to provide a ‘new and improved’ product design so as to affect prospects of that litigation.
(7)The rate of retraction was not out of the ordinary in relation to other IUDs in respect of which data is available.
(8)Retraction theoretically can increase the risk of transferring pathogens from the vagina to the uterus.
(9)The evidence does not establish that the fact of retraction and the rate of retraction increases the rate of PID on epidemiological evidence.
(10)There is no evidence of any difference in the incidence of PID where the strings of IUDs are made of different materials (except for Dalkon Shield).”
The next part of the judgment was headed “(c) Fraying”. This was followed by nine pages copied from the summary of the plaintiffs’ case, which duplicated what had already been copied from that source in Part 1 of the judgment “INTRODUCTION” under the sub-heading “Summary of Plaintiffs’ Case” and heading “2.1 Fraying of the tailstring”. Thereafter the trial Judge quoted two paragraphs from the defendants’ submissions and said:
“The essence of the plaintiffs’ case on this aspect is that Searle was negligent in using polypropylene probably rather than polyethylene. There was no evidence on behalf of the plaintiffs that polyethylene was ‘safer’. The epidemiological evidence established that there is no difference in the performance of IUDs using either polypropylene or polyethylene.
Professor Robertson conducted no comparative studies.
Professor Coughlin had obtained data which showed the performance was similar. (Ex D305 at para 119). This data was omitted from Coughlin et al 1992 by Professor Coughlin at a time when he was retained by plaintiffs’ lawyers and was aware that the lawyers thought Searle should have used polyethylene.
Dr Piziali (Ex D396, paras 45-54, 95-99) gave evidence that polypropylene had certain advantages over polyethylene in
(i) the manner of attachment to the IUD;
(ii) the surface area of the tailstring.
Dr Piziali calculated that the overall area of the fibrillated polypropylene was less than the alternative polyethylene.
It is clear from the evidence of Dr Piziali that drawing the tailstring material to produce higher tensile strength is a trade-off for fibrillation.”
The next sub-heading was “(b) ‘Ascension’ up the tailstring”. This again for over four pages duplicated material from the summary of the plaintiffs’ case already set out in Part 1 under the heading “Colonisation”. Bruce J said:
“The defendants dispute that there is evidence as demonstrated of movement of bacteria along the tailstring.
Professor Robertson on behalf of the plaintiffs suggested three mechanisms by which bacteria might migrate along the tailstring:
(a) direct migration
(b) sheer forces
(c) locomotion of the bacteria guided by chemotaxis.”
There followed a quotation from the defendants’ submissions. Bruce J said:
“The only bacteria found on any used IUD tailstrings was found encapsulated in biofilm. Professor Kaplan expressed the view that when bacteria are encapsulated in biofilm they remain so. (Ex D305, paras 29, 31& 34).
There is no evidence of continuous or semi-continuous bacteria which casts considerable doubt on (a) and (b) above.
In respect to attraction of bacteria by chemotaxis there was nothing to suggest that the presence of an IUD played any part in such movement if it occurred.
In relation to the dispute between the parties Professor Ellner who gave evidence on behalf of the plaintiffs indicated the importance of the number of bacteria entering the uterus in determining the risk of infection.
Professor Ellner also gave evidence in relation to a number of in vitro experiments carried out by Professor Fives-Taylor and others in relation to the ascension of bacteria. He was of the view essentially that they were of limited value because they did not mimic the in vivo conditions.
There was a vast amount of evidence given by Professors Fives-Taylor, Coughlin, Ellner and Katz on behalf of the plaintiffs and Dr Piziali and Professor Kaplin on behalf of the defendants relating to tailstrings and their characteristics. That evidence encompassed evidence of experiments and technical criticisms of those experiments and of opinions and counter opinions.
In my view the extraordinary complexity of these issues may be disposed of by determining the effect, if any, of the matters alleged by the plaintiffs on the health of users of Cu-7 device.
The matters raised are in my view advanced as possible causes of infection of users of Cu-7 devices. As I indicated above in my view the evidence does not indicate any statistically significant increase in the rate of infection and in my view there is no evidence that these issues had any effect on the health of users of Cu-7 devices.”
Effectively despite the “vast amount of evidence”, and “the extraordinary complexity of these issues”, the plaintiffs’ cases were disposed of in six lines and the scientific analysis cases were disposed of by reference back to the epidemiology cases, and were not dealt with on their own merits.
The remainder of the judgment was as follows:
“4.3 CLINICAL OBSERVATIONS
The plaintiffs sought to establish a causal connection between use of the Cu-7 device and the contracting of PID by the observation of treating doctors of the fact of the contracting of PID by users of Cu-7 and other devices.
In my view this submission has no substance whatsoever. There was no basis put forward for concluding that the mere observation of a condition which may occur with or without the use of an IUD in a person who uses an IUD is probative in any way of any causal connections between the use of an IUD and the contracting of PID.
The three areas of proof propounded by the plaintiffs, Epidemiology, the Scientific Analysis and Clinical Observations, do not either individually or together establish any causal association between the use of the Cu-7 devices and the incidence of PID.
5. WARNINGS
In my view the defendants did not fail to warn the plaintiffs of any matter of which they were required to warn.
The evidence does not establish that perhaps, despite the then current views, the devices increased the risk to users of the devices except as a result of the insertion procedure.
Counsel for the plaintiffs acknowledged that in the absence of an appropriate increased risk there was no duty to warn and the defendants had not breached any such duty.
The insertion procedure carried with it an element of risk which was known to all inserting doctors and of which they were all aware at the time of carrying out the relevant insertion.
In my view there was no requirement to warn medical practitioners of such an elementary matter nor was there any obligation to warn users of such a risk when they could only obtain access to use of the devices with the service of a doctor.
6. CONCLUSION
In my view the plaintiffs have not established that:
(1)Use of the Cu-7 IUD increased the risk of the user contracting PID by any statistically significant degree.
(2)There was not any negligence on the part of the defendants in the design and/or manufacture of the Cu-7 or Mini devices.
It is true that employees of the defendants expressed contrary views in relation to the tailstring of the device which indicated that there were defects in the devices but in the light of the evidence before me I am of the view that those views did not reflect correctly the effect of the matters referred to on the well-being of users of the devices.
A considerable amount of evidence was given as to the possible causes of the injuries which the plaintiffs each suffered. In my view the cause of the infection is not relevant to the determination of the liability of the defendants in the light of my conclusions.
It is clear that injury of the type sustained by each of the plaintiffs could have been sustained even if the devices had not been used and in my view the evidence does not establish as is required by the law of New South Wales that on the balance of probability the injury to the plaintiffs was caused or materially contributed to by the use of the devices.”
The defendants’ concession makes it unnecessary for us to say more about grounds 2 and 5 of the appeal than that the absence or insufficiency of reasons, particularly bearing in mind the delay in delivering them, pointed to a conclusion that the verdict should be set aside and a new trial ordered. See generally R v Maxwell (unreported) NSWCCA, 23 December 1998 at 24-25, a decision to which I will return.
The plaintiffs’ clinical observation cases were disposed of in one sentence, without any reasoning. The quite separate cases of failure to warn were disposed of all but summarily, without doing justice to the much more extended way in which the submissions show the cases were put forward. In the end, Bruce J’s conclusions all depended on his view that the epidemiological evidence did not reveal an increase in the risk of PID to users of the Cu-7. The reasoning to that view was itself deficient, but it did not follow from failure of the epidemiological evidence to establish an increase in the risk that there was no increase in risk, no duty to warn, or no causation in fact in the particular cases of the plaintiffs’ use of the IUDs. All this was not considered.
THE LIMITATION APPEALS
On 22 February 1999, the same date as he gave judgment in the liability proceedings, Bruce J gave judgment on the limitation applications. The circumstance of use of the IUDs and, accordingly, the date of accrual of the cause of action relied upon varied between the plaintiffs. One plaintiff had used the defendants’ IUD for the first time as early as 1975, and another plaintiff for the last time as late as 1985. Of the nine, eight began proceedings by summons filed between May 1989 and June 1990. The ninth plaintiff, Mrs Lee, began proceedings on 31 August 1993 by a statement of claim. This statement of claim was served on 25 October 1993. The other plaintiffs served statements of claim on dates from 29 November 1991 to 16 April 1992. For present purposes it can be accepted that each of the nine plaintiffs began proceedings out of time. Hence their applications for extension.
On 26 October 1992 the defendants’ application for leave to appeal from McInerney J’s orders of 31 July 1992 came before this Court constituted by Meagher, Handley and Sheller JJA. The application was adjourned pending the disposition of the limitation applications. On 22 November 1993 the leave application again came before this Court constituted by Kirby P, Handley and Powell JJA. The application was stood over to enable the plaintiffs to apply to have the hearing of the limitation applications expedited. On 20 October 1994 the proceedings came before Bruce J who indicated that the limitation applications would be disposed of before the cases started. His Honour observed: “You cannot run cases with that hanging over the proceedings for all sorts of reasons.” The hearing of the limitation applications began before Bruce J on 12 December 1994 and was completed by 20 December 1994 except for the evidence of one witness whose absence meant that there were further hearings on various dates until 2 March 1995.
No decision was given before the hearing of the liability proceedings began on 29 January 1996.
The defendants opposed extension on grounds which included what was described as tactical delay illustrated by the delay of about 15 months between the filing and the serving of the initiating summons and the delay in commencing the proceedings. The defendants also relied upon irreparable prejudice to them in dealing with allegations the circumstances of which dated back to the early 1970s and the prejudice resulting from the inaccuracy and deficiency of information supplied about the medical care providers to the plaintiffs. The plaintiffs were cross-examined as was their solicitor, Dr Cashman.
For present purposes I do not think it necessary to dwell upon the circumstances and result of an application to Bruce J on 7 August 1998 to disqualify himself. On 12 August 1998 in dismissing the application his Honour said it was grounded on allegedly partisan statements and a pre-determination issue.
The single set of reasons Bruce J gave on all nine limitation applications was seven pages (2-8) long. The last page consisted of two lines. Bruce J set out the relevant parts of ss 60G and 60I(1) of the Limitation Act which are as follows:
“Ordinary action (including surviving action)
60G(1) This section applies to a cause of action that accrues on or after 1 September 1990, founded on negligence, nuisance or breach of duty, for damages for personal injury, but does not apply to a cause of action arising under the Compensation to Relatives Act 1897.
(2)If an application for an order under this section is made to a court by a person claiming to have a cause of action to which this section applies, the court, after hearing such of the persons likely to be affected by the application as it sees fit, may, if it decides that it is just and reasonable to do so, order that the limitation period for the cause of action be extended for such period as it determines.
Matters to be considered by court
60I(1) A court may not make an order under section 60G or 60H unless it is satisfied that:
(a) the plaintiff:
(i) did not know that personal injury had been suffered; or
(ii) was unaware of the nature or extent of personal injury suffered; or
(iii) was unaware of the connection between the personal injury and the defendant’s act or omission,
at the expiration of the relevant limitation period or at a time before that expiration when proceedings might reasonably have been instituted; and
(b)the application is made within 3 years after the plaintiff became aware (or ought to have become aware) of all 3 matters listed in paragraph (a) (i)-(iii).”
No mention was made in the judgment of Schedule 5 of the Limitation Act, cl 4 of which provides, so far as relevant, as follows:
“4.(1) Section 60G also applies to a cause of action, founded on negligence, nuisance or breach of duty, being a cause of action that accrued or would have accrued before 1 September 1990, but does not apply to a cause of action arising under the Compensation to Relatives Act 1897.
…….
(4) The court may make an order under section 60G or 60H, in relation to a cause of action referred to in this clause if an application for such an order is made within:
(a)the period of 3 years referred to in section 60I; or
(b)the period of 3 years commencing on 1 September 1990.”
On page 3 the judgment continued as follows:
“The relevant knowledge of the plaintiff is not of a connection between the defendants’ product (the Cu-7) and her injury but it must be between the defendants’ ‘act or omission’ and her injury (Dedousser [sic Dedousis] v The Water Board (1994) 69 ALJR 1) [(1994) 181 CLR 171].
The plaintiffs did not personally know of the connection between any ‘acts or omissions’ at times which would disentitle them to the exercise of the court’s discretion. The defendants conceded that they had to lose the question of knowledge unless they could attribute some part of the knowledge of the plaintiffs’ solicitor to each plaintiff. Thus the questions are whether the knowledge of the plaintiffs’ solicitor was sufficient to disentitle them and whether it was attributable to them.
The plaintiffs submitted, in effect that when s60I(1) refers to ‘the plaintiff’ it means ‘the plaintiff’ and does not include some other person (such as the plaintiffs’ solicitor) who may have the relevant knowledge.
The terms of s58 and s60I differ in that the former refers to ‘means of knowledge’ of the plaintiff and obviously included knowledge of a legal representative of the plaintiff whereas s60I refers to ‘the plaintiff …was unaware’.
The primary argument advanced by the defendants in support of the conclusion that ‘the plaintiff’ includes the plaintiff’s legal representative is that if the legal representative did not report in sufficient or in adequate detail then s60I(i) (ii) [sic s60I(1)(a)(i) and (ii)] might be satisfied even though the legal representative is aware of the relevant matter. It was said that the legal representative is an agent for knowledge so as to fix the plaintiff with the knowledge of the legal representative particularly in litigation where there is a group of plaintiffs.
I do not accept that this is so. When the legislation is considered it draws a distinction between means of knowledge (s58) and awareness (s60I). In my view the tests propounded by the legislation are different and the fact that it may be that a legal representative knows of some matter but has not communicated it to the plaintiff means that the plaintiff is ‘unaware’ within the meaning of s60I does not lead to the conclusion contended for by the defendants.
However, in any event, in the circumstances of these cases the plaintiffs’ legal representative did not develop an awareness, as opposed to a suspicion, of the relevant connection until October 1990 having commenced accreting facts in July 1989.
In my view the fact of the earlier institution of proceedings in some cases does not, in the present cases lead me to the conclusion that the requirements of s60I(1) (iii) [sic s60I(1)(a)(iii)] have not been satisfied. In addition I accept that the plaintiffs personally were unaware of the connection between their personal injury and ‘the defendants’ act or omission’ as opposed to the defendants’ product.
In my view it is appropriate to exercise my discretion to extend the time for the institution of proceedings in each case up to the time that proceedings were instituted.
The litigation is extremely complex technically and plaintiffs and their legal representatives were justified in giving earnest consideration to proceeding with such litigation.
In my view the prejudice which might be suffered by the defendants in the conduct of the litigation is not such as to justify declining to exercise the discretion to extend time bearing in mind the fact that there had been considerable litigation in the United States relating to the same products.
The general delay and its consequences, while they are in the usual class of litigation significant factors to give weight to in determining the exercise of the discretion to extend time, do not operate to the same extent in the circumstances of these cases to preclude the proper exercise of my discretion to extend time for the institution of common law proceedings.
I am conscious of the views of McHugh J in Brisbane South Regional Health Authority v Taylor (1996) 139 ALR 1 [(1996) 186 CLR 541] in relation to the extension of time and to his view of presumed prejudice by lengthy delay but in these cases such presumed prejudice is insufficient to preclude the exercise of my discretion to extend time.
In further written submissions the defendants raised a number of matters of prejudice and many specific allegations of prejudice in respect of each plaintiff. I have considered these matters individually and collectively but in my view they do not lead to the result that I should not exercise my discretion in favour of the plaintiffs. The nature of the plaintiffs’ cases and of the circumstances surrounding the delay in the institution of proceedings [are] such as to persuade me to exercise my discretion and I do so.
In so far as it is necessary for the plaintiffs to show that a cause of action exists there was voluminous evidence to this effect which I do not propose to canvas in the judgment.”
The rest of the judgment consisted of a heading and seven lines about the Trade Practices Act 1974. This part of the judgment is not presently relevant.
The defendants submitted that the reasons were inadequate and failed to deal with part of their argument. If leave was granted, the defendants sought on the limitation appeals orders that the applications be remitted to the Common Law Division for re-hearing.
Mr Walker informed us that by about the middle of 1995 the entirety of the issue in relation to the limitation applications had been concluded so far as the parties were concerned and judgment was being awaited. At the trial which began in the following January, the plaintiffs and their treating doctors and the doctors responsible for inserting the IUD were cross-examined. Part of that cross-examination was designed to demonstrate the unreliability of recollections. Part of the written submissions prepared by the defendants was called Chapter XII. This was a supplement both as to the law and extra factual material in support of the defendants’ opposition to the limitation applications. In his final submissions to Bruce J on 20 November 1997 Mr Walker referred to Chapter XII and addressed on it. On 23 December 1997 judgment was reserved on all the issues argued.
Chapter XII was forty pages long. It dealt first with what were said to be recent developments concerning relevant limitation periods. Harris v Commercial Minerals Limited (1996) 186 CLR 1 which was published on 3 April 1996 was referred to, particularly at 9-10 where the Court held that, in considering whether the plaintiff was unaware of the nature or extent of personal injury suffered (s60I(1)(a)(ii)), to look to anything other than “the applicant’s actual awareness of the matters referred to in sub pars (ii) ….. would be to read into s60I(1)(a) a doctrine of constructive notice that is not justified by the language of the provision.” Although this was an issue before Bruce J and his Honour found that the plaintiffs personally were unaware of the connection between their personal injury and the defendants’ act or omission, he made no reference to Harris. In Harris at 14 the Court said:
“After the applicant gets through the s60I(1) gateway, he or she must satisfy the Court that it is ‘just and reasonable’ (s60G) to grant an extension of the limitation period. Under that provision, questions of what the applicant knew or ought to have known will often play a critical role in determining whether it is just and reasonable to extend the limitation period. It may not be just and reasonable, for example, to extent the limitation period if before the expiration of the period the applicant knew or ought to have expected most of the consequences of an injury. Unawareness of all the consequences may get the applicant through the s60I(1)(a)(ii) gateway, but it will not guarantee a passage through s60G.”
Bruce J did not appear to consider whether the plaintiffs had passed this second gateway.
The defendants put submissions based on the High Court’s decision in Brisbane South Regional Health Authority v Taylor which was delivered on 2 October 1996 and to which Bruce J did refer. It was submitted that the discretion given to the Court was a discretion to grant, not to refuse, the extension, and that the onus was on each plaintiff to establish that an extension would not result in significant prejudice to the prospective defendants, that, despite the delay, a fair trial was still possible and that the justice of the case warranted an exercise of discretion. The ultimate onus remained on the applicant plaintiff. The defendants submitted that once the Court made a finding of actual prejudice a decision to dismiss the application was inevitable.
A substantial part of the Chapter XII submissions was directed to the prejudice the defendants claimed to have suffered as a result of what was called the “long and unjustified delay between commencement of proceedings and service of process”. Attached was material about the health care providers to each of the plaintiffs. Emphasis was placed upon deficiencies in the material provided.
The Chapter XII submissions identified particular prejudice suffered by the defendants in each action and relied on discrepancies between the schedules of health care providers furnished by individual plaintiffs and the position revealed by the Health Insurance Commission (“HIC”) in notices of past benefits under s21 of the Health and Other Services (Compensation) Act 1995. A comparison in the case of one plaintiff showed that she claimed to have nine health care providers between 1958 and the date of the service of the schedule whereas the HIC had issued a notice of past benefits which disclosed at least 53 health care providers between February 1984 and January 1997. The defendants submitted that the discrepancies were so great that, in a case where damages were sought for alleged ongoing conditions said to be caused by the defendants’ wrongdoing, the Court could not be satisfied that the defendants could have a fair trial of that issue when so much evidence of subsequent treatment had been suppressed.
Chapter XII went on to submit that the testimony of all witnesses, and especially that concerning the critical dealings between patients and doctors were evidently based on reconstruction not real recollection. Many medical records had been lost through the passage of time. The extent of the prejudice encountered by the defendants could be gauged by the scope of evidence thus rendered unreliable by the plaintiffs’ delay in commencing proceedings. In Chapter XII there were listed in respect of each plaintiff instances of unsatisfactory purported recollections, lists of medical records spoiled, destroyed or lost and lists of missing doctors.
The four paragraphs of the reasons for judgment, which begin “In my view, the prejudice” and which I have already quoted, suggest that, contrary to the decision of the High Court in Brisbane South, Bruce J proceeded on the basis that the discretion was a discretion to decline to extend time with the consequence that the onus was on the defendants. The two paragraphs that followed gave no explanation or reason for the conclusion that the general delay and its consequences did not operate “to the same extent in the circumstances of these cases to preclude the proper exercise of my discretion to extend time for the institution of common law proceedings”. This extract from the judgment suggested that his Honour took as a starting point that he would exercise the discretion unless he was persuaded otherwise by the defendants.
The paragraph in Bruce J’s judgment that refers to Brisbane South treated that decision as mere commentary rather than binding authority and again gave no explanation why presumed prejudice was insufficient “to preclude the proper exercise of my discretion to extend time”. In the light of what had been said previously it is quite clear that his Honour misunderstood what the High Court had said about the nature of the discretion and when it would be exercised. This was carried forward into the next paragraph which gave no explanation for the conclusion. To these general arguments can be added the consideration that, after the lengthy delay in delivering judgment, Bruce J gave no proper attention to the arguments advanced.
R v Maxwell was an appeal from a decision of Bruce J. His Honour gave judgment finding the appellant guilty of murder some ten months after the decision was reserved. The Court of Criminal Appeal (Spigelman CJ, Sperling and Hidden JJ) adopted had been said by the English Court of Appeal in Goose v Wilson Sandford & Co (unreported) 13 February 1998 and said:
“Considerations such as these have informed this Court in its review of the reasons for judgment given by his Honour, specifically the statements made by his Honour in his judgment of a general assertive character, which in the normal course would be accepted as encompassing a detailed consideration of the evidence before him, have been treated by us with reserve. Indeed, a delay of the order of ten months, is, of itself, such as to require a more comprehensive statement of the relevant evidence than would normally be required, in order to manifest, for the parties and the public, that the delay has not affected the decision. For the reasons we will give below, his Honour’s judgment is unsatisfactory in this regard. His Honour failed to give reasons of a character which the law required him to give in all the circumstances of the case, including the circumstance of the delay between the trial and delivery of judgment.”
Later in the judgment the Court of Criminal Appeal reiterated that the delay in delivery of judgment made it even more necessary than usual for the Judge to err on the side of thoroughness in the exposition of his reasoning process. Their Honours said:
“The appellant had a right to expect that the arguments put on his behalf would be dealt with in such a way that he could be satisfied that they had been understood and, either accepted, or, if rejected, that the rejection was based on a clear and rational process of reasoning.”
In Flannery v Halifax Estate Agencies Limited Henry LJ at 381-2 made some general comments on the duty to give reasons, which I have quoted in part. The extent and nature of this duty is well known; see for example Soulemezis v Dudley (Holdings) Pty Limited (1987) 10 NSWLR 247 and the judgment of Mason P in Beale v Government Insurance Office of NSW (1997) 48 NSWLR 430 at 431, 436-7 and 439-441.
There could, I think, be no doubt whatever that Bruce J failed to fulfil this duty in giving judgment on the limitation applications, particularly bearing in mind the significance of the delay in giving judgment and what was said about that by the Court in Maxwell, a decision given before Bruce J delivered his judgment. As we indicated at the conclusion of the argument, the defendants are entitled to have the orders made by Bruce J set aside and the limitation applications re-heard. I recognise the force of the submissions by Dr Cashman, on behalf of the plaintiffs, that any re-hearing may require the plaintiffs again to submit to cross-examination. However, in my opinion, the Court has no choice.
This being so it is unnecessary to say anything about the decision of the High Court in John Pfeiffer Pty Limited v Rogerson (2000) 74 ALJR 1109 and the law that must now be applied in resolving the limitation applications.
DIRECTIONS AS TO NEW TRIAL
Dr Cashman submitted that this Court should give directions about the way in which the new trials be conducted. He relied upon s75A(10) of the Supreme Court Act 1970 which enables the Court to “make any finding or assessment, give any judgment, make any order or give any direction which ought to have been given or made or which the nature of the case requires.” Dr Cashman submitted that this Court should give directions to the Court re-hearing the liability proceedings and the extension applications that it do so “on the papers” by which was meant, as I understand it, on the transcript of evidence and the exhibits admitted in evidence before Bruce J.
I do not think it appropriate for this Court to intrude on the general discretion of the Judge assigned to hear the new trials by giving any directions as to how the Judge should undertake that task. Certainly this Court should not order that such a trial be conducted “on the papers”. It may be that the length and complexity of the new trials can be reduced by appropriate admissions or agreement. However, those are matters to be dealt with at trial.
COSTS
The defendants did not contend that they should not pay the plaintiffs’ costs of the appeal in so far as those costs were incurred in preparing and presenting the appeal on grounds 2 and 5. The plaintiffs did not contend that they should not pay the defendants’ costs of the limitation appeals. The area of debate was whether the plaintiffs were also entitled to their costs in respect of the other grounds of appeal not fully argued or, put another way, whether the plaintiffs should have all their costs of the liability appeal. The plaintiffs also sought the costs of the liability appeal on an indemnity basis.
Section 76(1)(c) of the Supreme Court Act enables the Court to order costs to be assessed on an indemnity basis. It has been said that an award of indemnity costs pre-supposes some relevant delinquency by the party against whom the order is made. The plaintiffs relied on the decision of this Court in Huntsman Chemical Company Australia Limited v International Pools Australia Limited (1995) 36 NSWLR 242 to submit that the defendants were delinquent because of delay in making the concession that there should be a new trial.
In that decision a question was whether an appellant, which abandoned its appeal on the morning of the hearing, should pay the respondent’s costs of the appeal on an indemnity basis. The majority of the Court (Kirby P and Mahoney JA) thought not. At 249-250 Kirby P said:
“The merit of the present motion is that it calls attention to the distinct possibility that, in some circumstances, a special costs order will be made, including for indemnity costs. If such an order is to be made, it would be preferable that it should follow due and timely warning by the successful party to the unsuccessful that indemnity costs will be sought…. In short, if the legal representatives of parties to an appeal (particularly perhaps in commercial litigation such as the present) consider that the appeal, or points in it, are obviously hopeless and doomed to fail, they would be well advised to warn their opponents that continued prosecution of the appeal, or of the hopeless points, will result in an application to the Court for a special costs order.”
At 251-2 Mahoney JA said:
“The central consideration, or at least an important consideration, relied on by International in seeking indemnity costs in this case is that referred to by Rolfe AJA, namely, that International was informed of the decision of Chemplex not to pursue the appeal against it only very shortly before the hearing. Chemplex has not advanced a satisfactory reason why that decision was not made earlier or why it did not inform International of the decision at a time when International’s costs of the appeal might have been considerably less. I am conscious of the danger of drawing inferences from inadequate evidence or lack of evidence. But it is, in my opinion, proper to infer that, whilst Chemplex opted to pursue the proceedings against Ferro, it decided not to pursue them against International because the appeal against International was hopeless. If this be so, that would have been apparent at or about the time of the filing of the appeal, or at least, shortly after. I am appreciative of the practicalities of litigation: decisions in litigation are not all made at the earliest time and parties do not, and perhaps cannot be expected to, manage their affairs in the most efficient way. But, even if the matter be approached on such a basis, the fact that International was obliged to incur costs up to the day of the hearing or shortly before is a factor which must weigh heavily in support of the award of indemnity costs.
However, the present application was made by International initially at the commencement of the hearing of the appeal proceedings between Chemplex and Ferro. The Court does not have before it evidence which in terms explains what happened in the present matter. There is no formal evidence as to the course of dealings, if any, between Chemplex and International prior to the date fixed for the hearing of the appeal and, subject to what I have said, the Court must speculate as to what, if any discussions took place. My mind has wavered but, in the end, notwithstanding the considerations to which Rolfe AJA has referred, I am not satisfied that the case is one in which indemnity costs should be awarded. I therefore concur in the order as to costs proposed by Kirby P.”
In dissent, Rolfe AJA said at 273:
“In the present appeal full argument has been presented and, in my opinion, costs on an indemnity basis should be awarded. This is not to discourage appeals but to indemnify International fully in the particular circumstances. The discussion about discouraging appeals only arose from the suggestion that unmeritorious appeals would be argued out fully if indemnity costs were awarded. However Premier Woodworking Co Pty Ltd v Siganisucu (unreported) Court of Appeal 30 November 1989, stands as authority for the making of a more expansive order for costs than costs on a party and party basis.
In my opinion the authorities support the proposition that where a party persists in a hopeless case, that justifies, for all the reasons given, the making of an order for costs on an indemnity basis.
It was submitted that there may be good reasons why parties would seek to withdraw an appeal on the hearing, quite unconnected with any acceptance that the appeal was hopeless. If there are such reasons then evidence should have been placed before the Court to explain them. The Court expressly reserved leave to the appellants to call evidence on the application if they saw fit. No such evidence has been put before the Court. The onus was clearly placed upon the appellants, which were the parties aware of the reason for not pursuing the appeals, to satisfy the Court the reasons were sufficient. They have not sought to discharge it.”
In the liability appeal, we were not concerned with an appellant pursuing a hopeless appeal. We were concerned with respondents defending a judgment in their favour. There is now a procedure for dealing with such a situation, if the appellant thinks fit, by a Calderbank letter or an offer to compromise under Part 22 of the Supreme Court Rules. Neither course was followed.
Before the concession was made, Mr Walker for the defendants mounted a careful and inevitably complex argument that the plaintiffs’ case was that the IUD increased the risk of the introduction of infection into the uterine cavity or the fallopian tubes or to the ovaries. Accepting that the liability judgment was defective for want of reasons and otherwise, Mr Walker submitted that however one approached the plaintiffs’ case, the epidemiology of PID was at the heart of it. The evidence before Bruce J if properly understood, it was said could only lead to the plaintiffs’ case, so founded, failing. Accordingly, any new trial would be futile. The argument was a difficult one to maintain and in the end the concession was made but I do not think the defendants were putting so obviously a hopeless position which was doomed to fail that they should suffer in costs.
Nor do I think the defendants can be held guilty of any delinquency in seeking to defend the judgment in their favour even if it were thought that they had small prospects of supporting a judgment which was manifestly defective. I am not persuaded there is any basis upon which the plaintiffs are entitled to their costs of the appeal against the defendants on an indemnity basis.
COSTS OF OTHER GROUNDS OF APPEAL NOT ARGUED
In the course of case management, full written submissions were prepared by the parties on grounds 1 and 3 of the appeal: to repeat, they were described in the synopsis of the grounds of appeal as follows:
“1.Judicial incapacity or reasonable apprehension of judicial incapacity incompetence and/or bias.”
“3.External pressure or reasonable apprehension of external pressure.”
These grounds as expanded were:
“1. JUDICIAL INCAPACITY OR REASONABLE APPREHENSION OF JUDICIAL INCAPACITY, INCOMPETENCE AND/OR BIAS
1.1In February 1998, in support of his own case before the Conduct Division of the Judicial Commission of New South Wales, his Honour had led evidence as to his psychological state of health. This evidence included the opinion of Dr Dent that his Honour was capable of continuing in his judicial duties. Dr Dent said that the proof of the therapeutic pudding would [be] in its consumption although would be surprised if his views were not validated. In these circumstances his Honour was in error in not providing a fully reasoned judgment in each of the nine cases.
1.2There are grounds for reasonable apprehension of judicial incapacity, incompetence and/or bias:
(a) during the course of the trial and/or
(b)during the period during which judgment was reserved and/or
(c)at the time of the delivery of the judgment
on the basis of the cumulative effect of, inter alia:
(1)the findings of the Judicial Conduct Commission;
(2)the findings of the NSW Court of Criminal Appeal in Maxwell;
(3)the evidence, including the evidence of Dr Dent, relied upon by his Honour in the proceedings before the Judicial Conduct Commission;
(4)the further complaints and Judicial Conduct proceedings immediately before the delivery of judgment;
(5)the conduct of the defendants in the present proceedings;
(6)the delay in the delivery of judgment in the present (and other) proceedings;
(7)the circumstances surrounding the application for disclosure made on behalf of the plaintiffs on 4 March 1999 and his Honour’s failure to make the disclosure requested;
(8)the manifest errors and inadequacies on the face of the judgment in the present proceedings (see below).
1.3His Honour erred in failing to make disclosure, notwithstanding the findings of the Conduct Division of the Judicial Commission of New South Wales on 15 May 1998, of the making of a further complaint to the Conduct Division of the Judicial Commission of New South Wales and proceedings before the Division in respect of that complaint prior to his decision in these proceedings being delivered on 22 February 1999.
1.4His Honour erred in failing to make disclosure of communications regarding such further complaints prior to making orders as requested by senior counsel for the plaintiffs at the hearing on 4 March 1999.
1.5His Honour was in error in failing to disqualify himself (a) when it became evident or should have become evident to his Honour that there was a reasonable apprehension of bias and (b) when he did not respond to the request by senior counsel for disclosure on 4 March 1999.
1.6His Honour was in error in failing to disqualify himself for reasonable apprehension of bias. In all circumstances a reasonable observer would think that his Honour may have been unable to produce 9 judgments (see below).
1.7His Honour was in error in continuing in the case from the date in 1998 when circumstances existed which he believed (and stated at the time of delivering his judgment) meant that it was in the overall interest of administration of justice that he not continue to be a Justice of the Supreme Court.
3.EXTERNAL PRESSURE OR REASONABLE APPREHENSION OF EXTERNAL PRESSURE
3.1There are reasonable grounds for apprehension of external pressure, or undue pressure arising out of other judicial obligations, (or delay and/or default in the performance of other judicial obligations) such that:
(1)his Honour was unable to devote any or any sufficient time to (a) evaluating the evidence at trial (b) considering the written and oral submissions of the parties (c) writing a judgment;
(2)the judgment was belatedly prepared some considerable time after the completion of the evidence of witnesses who appeared at the trial.
3.2There are reasonable grounds for apprehension that during the period during which judgment in the present proceedings was reserved, his Honour was incapable of spending any or any sufficient time on writing a judgment given:
(i) his incapacity; and/or
(ii)the necessity and pressure to deal with other matters, including:
(I)outstanding reserved judgments in other matters;
(II)complaints of delay in handing down reserved judgments in other cases;
(III)proceedings before the Conduct Division of the Judicial Commission in the period from 10 December 1997 to the completion of the report of the Division on 15 May 1998;
(IV)proceedings instituted by his Honour before the NSW Court of Appeal for the purpose of seeking to prevent the tabling in Parliament by the Attorney General of the report of the Judicial Commission of NSW;
(V)proceedings before the Legislative Council of the Parliament of NSW, including the appearance of his Honour, arising out of the finding by the majority of the Judicial Conduct Division of the Supreme Court of proven incapacity on the part of his Honour to perform his judicial duties such as to justify parliamentary consideration of the removal of his Honour from the office of Judge of the Supreme Court of NSW;
(VI)attendance upon solicitors and counsel in connection with a number of the matters referred to above;
(VII)the further complaint by the Chief Judge in Common Law, Justice Wood, made to the Judicial Commission in or about January or February 1999;
(VIII)the complaint made to the Chief Judge in Common Law, Justice Wood, by the defendants in the present proceedings in or about February 1999;
(IX)the further proceedings before the Conduct Division of the Judicial Commission in February 1999.
3.3In circumstances where it is on the public record that his Honour had given sworn evidence before the Conduct Division of the Judicial Commission of New South Wales that he would make expositions of fact in relation to each of the nine plaintiffs, his Honour was in error in that he delivered judgment without providing any reasoned judgment with respect to the individual merits of any of the nine cases.
3.4In circumstances where his Honour had stated in the course of the hearing that he would provide draft judgments and stated in his judgment refusing to disqualify himself on the defendants’ application that draft judgments would be provided to the parties for their submissions, his Honour was in error in not providing a reasoned judgment in respect of each plaintiff.
3.5His Honour was in a position where he was under great pressure to deliver judgment so that he could resign. To give judgments for each of the nine plaintiffs would have required preparation of nine judgments with reasons and facts. In the event his Honour provided one judgment in all cases deciding the cases generically. There would be a reasonable apprehension that this was a short cut.”
Fortunately these grounds of appeal were of a novel nature. They would have involved this Court setting aside a judgment on the ground that the Judge was incompetent at various times and this in the face of the defeat in Parliament in June 1998 of a prayer for the dismissal of Bruce J on grounds of incapacity or incompetence. It would, in my opinion, be entirely inappropriate for this Court in the absence of full argument to speculate on the outcome of the appeal on these grounds. That leaves the question of how the costs incurred by the parties should be borne. In my opinion, there is no basis upon which this Court can make any order as to the costs incurred by the parties in respect of these grounds of appeal. They neither succeeded nor failed: compare Elliot v Rokeby [1881] 7 AC 43 at 46; Lloyd-Jones v Clark-Lloyd [1919] 1 Ch 424 at 457; Jamal v Secretary, Department of Health (1988) 14 NSWLR 252 at 271-2.
ORDERS
I have set out the orders made by the Court on 8 September 2000.
In my opinion, the costs order should be as follows:
(a)The defendants to pay the plaintiffs’ costs of the liability appeal on grounds 2 and 5 of the synopsis of grounds of appeal but to have a certificate under the Suitors’ Fund Act 1951 if so qualified.
(b)The costs of the hearing of the liability proceedings before Bruce J will be in the discretion of the Judge re-hearing the proceedings or in the discretion of a Judge of the Common Law Division.
(c)The plaintiffs to pay the defendants’ costs of the limitation appeals but to have a certificate under the Suitors’ Fund Act if so qualified.
(d)The costs of the hearing of the limitation applications before Bruce J will be in the discretion of the Judge re-hearing those applications or in the discretion of a Judge of the Common Law Division.
BEAZLEY JA: I agree with Sheller JA.
GILES JA: In this case it is appropriate that there be an explanation of the circumstances in which the defendants conceded that the reasons of Bruce J were inadequate and the orders of 8 September 2000 relating to the liability appeal were made. I respectfully adopt the account in the reasons of Sheller JA. I also adopt the reasons given by his Honour for the orders of 8 September 2000 relating to the limitation appeals, and agree with the orders proposed by his Honour as to costs and with his Honour's reasons for those orders.
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LAST UPDATED: 24/11/2000
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