The immune response issue
81 Ms Jancauskas deposed that the immune response issue arises from a question I asked during final addresses on 13 February 2018 when I inquired of Mr Graham SC, who was then appearing for the applicants, whether the absence of a warning about not using mesh in patients with an autoimmune disorder was in the pleadings. The inquiry was made at a point during the oral argument when Mr Graham referred to evidence in the case of Kathryn Gill, the first applicant, who suffered from psoriasis at the time she was implanted with one of the respondents' devices, known as Prolift. The evidence was given without objection by Dr Robyn Leake, who implanted the device. She said:
In addition, in her case an auto-immune disorder, psoriasis, might have predisposed her to some complications, due to idiosyncratic scarring of tissue around the Prolift mesh implant. I do not recall any warning being provided by Prolift's manufacturer about not using the mesh in patients with an autoimmune disorder.
82 Evidence had also been given that after Mrs Gill's operation a warning was included in the IFU issued with Prolift and two other Ethicon devices - Gynemesh PS and Prolift+M - in the following terms:
In patients with compromised immune systems or other conditions that would compromise healing, the risks and benefits should be carefully weighed.
83 No answer was given to my question. The answer, however, is provided by the present application. The applicants' pleading did not include a claim that Ethicon had failed to warn about the risk implanting the devices might pose for women with autoimmune disorders. By the present application, the applicants seek to add to paragraphs 23C and 48 respectively of their statement of claim allegations that the respondents failed to give any, or any sufficient, information or warnings "that the chronic inflammatory response to the [devices] may be affected by conditions which affect the immune response and healing, including autoimmune and connective tissue disorders".
84 In her affidavit Ms Jancauskas referred to other evidence on the subject. One was a letter tendered by the respondents from the United States Federal Drug Administration (FDA) dated 12 October 1990 to James O'Donnell, Manager of Regulatory Affairs at Ethicon Inc notifying the company of the reclassification of its nonabsorbable polypropylene suture, Prolene. The letter adverted to potentially delayed wound healing in patients with compromised health due to a number of factors.
85 Amongst the material to which Ms Jancauskas referred was evidence given (without objection) by Professor Andrew Korda, one of the urogynecologists called by the applicants. Another was evidence proffered by the respondents themselves from a biomaterials expert, Professor Paul Santerre, concerning the host response to biomaterials like pelvic mesh. It is sufficient at this point to refer to the Professor Korda's evidence. I will return later to Professor Santerre.
86 Professor Korda stated in his third report dated 30 March 2017 that:
[P]atients with vaginal atrophy who smoke or who use immunosuppressant medications should not undergo mesh implant surgery. Such contraindications should be listed in the manufacturer's instructions for use.
87 In oral evidence the professor was asked by Mr Bannon SC for the applicants why patients with those attributes should not undergo mesh implant surgery (ts 1188). He replied:
It actually came out of a study that was performed by the European mesh group that looked at this about five or six years ago and identified patients at high risk. What they found is that patients at high risk were those who have immunosuppressed conditions, for instance, rheumatoid arthritis or any other type of immune disease and/or smoking is associated with a lowered immune response, and, obviously, vaginal atrophy is another condition that doesn't allow you to dissect the vagina as thickly as we saw on that lady in the video. But this is information that was not around until the inquiry.
88 Mr Bannon asked him what he meant by his statement that the information was "not around". He answered that obstetricians, gynecologists, and urologists "did not know that people who were immunosuppressed shouldn't have mesh". He was not challenged about this evidence in cross-examination.
89 Ms Jancauskas also noted in her affidavit evidence given by Mrs Gill about her psoriasis, including a statement in her first affidavit, affirmed on 27 July 2016, that she would not have consented to the implantation of the Prolift device if she had been told that the mesh was unsuitable for patients with an autoimmune disease like psoriasis. This evidence, along with other evidence from Mrs Gill as to what she would have done had she been warned about other risks said to arise from the Prolift, was admitted without objection but subject to an order sought by the respondents that it be limited under s 136 of the Evidence Act 1995 (Cth) to proof of the statutory counts, it being inadmissible for the purposes of the negligence claim because of the terms of the Civil Liability Act 2002 (WA). Ms Jancauskas also referred to Dr Leake's evidence extracted above.
90 The applicants submitted that in the light of this evidence, there would be prejudice to some group members, and in particular Mrs Gill, "should the Court take the view that the issue falls outside the current pleading". In this context, they submitted that the proposed amendments are "relatively minor". The current pleading includes an allegation that the implants "have a risk of or were susceptible to … causing a chronic inflammatory reaction or an inflammatory reaction which [was neither minimal nor transient]" and that the respondents failed to give any or sufficient information or warning about it. The applicants stressed in oral submissions that the parties dealt with the broader issue of chronic inflammatory reaction in "agonising" detail. All the proposed amendments do is single out a particular class of women who may be or are particularly "at risk" or "susceptible". On one view, then, the proposed amendments are unnecessary.
91 The respondents submitted that the allegation is outside the scope of the current pleading and the proposed amendments should be disallowed for a number of reasons, none of which is persuasive.
92 First, the respondents contended that they had made forensic decisions based on the current pleading, implying that they could have tendered evidence to respond to the proposed new pleading. They said that Professor Korda was not cross-examined on his evidence on this question because it was unnecessary having regard to the pleaded case. For the same reason, they submitted, nor was Mrs Gill or Dr Leake. Further, while Professor Santerre gave evidence about the variability of the host response, the respondents said he was not examined in chief or cross-examined about knowledge of those matters, which, they submitted is integral to any asserted failure to warn.
93 I accept, as the respondents submitted, that they broadly structured their closing submissions by reference to the pleaded complications, going through each to show why a warning (or a different warning) was not required, in the light of what specialist surgeons (responsible for implanting the devices) "generally" knew. It may also be accepted that their approach to the evidence they gathered and adduced could have been motivated by this strategy.
94 The assertion in the respondents' submissions that they had made a forensic decision based on the absence of the proposed allegation in the current pleading was not supported by evidence. But Mr Graham SC did not question the assertion. In the circumstances I accept it. As the applicants pointed out, however, there is no reason to think that the respondents would have made different decisions if the matters raised by the proposed amendment were expressly pleaded.
95 Having regard to the allegation that the implants could cause a chronic inflammatory reaction or an inflammatory reaction which was not minimal or transient and that the respondents failed to provide any information or warning to that effect, the evidence given by Professor Korda was relevant and probative. If there was any issue about it, no doubt he would have been cross-examined.
96 In view of what Professor Santerre had said in his first report, there could not have been a genuine issue. The obvious reason he was not examined in chief on the question was because he had already given evidence in chief. He said in his first report that the response to the implantation of a foreign body, like the devices, will vary from patient to patient but that polypropylene mesh "would likely be the wrong choice of a material by the surgeon for a patient with any compromised immune system which could delay tissue integration with the mesh". Earlier in his report he explained:
55 Immune response will depend on a patient's genetics (inherently has an active or compromised, or moderate immune reactivity), disease state (e.g. diabetes, connective tissue disorders, blood disorders), age (young people typically have much more active and accommodating wound healing than older patients), gender, extent of injury (e.g. more damage to local tissues from the surgical process will generate a greater inflammatory reaction and more challenging host response), environmental conditions (smoking, diet, stress, etc.) and sensitivity to biomaterial chemistry (non-common patient allergies). … If new tissue cannot integrate fast through a porous biomaterial then the material can possibly dislocate, and in some cases ultimately migrate and protrude from the unresolved surgical insertion site.
56. Hence, it follows on to say that not all patients will achieve a successful integration of biomaterials with new tissue because it is well known that the above parameters compromise wound closure and healing for some patients. If wound healing is different from one human to another, then it also follows that wound healing differs between species. Hence, animal models are not absolute substitutes for human clinical trials and pre-market evaluation.
(Emphasis added.)
97 Several sources were given for the statement in the first sentence of [56]. The earliest was a 1997 publication. The first of the Ethicon devices was not on the market in Australia at that time.
98 On the assumption that the failure to warn about the risk to patients with compromised immune systems is not caught by the current pleadings, the observation by Dawson J in Banque Commerciale SA (In liq) v Akhil Holdings Limited (1990) 169 CLR 279 at 296-7 is apposite. That observation, cited with approval by five justices of the High Court in Vale v Sutherland (2009) 237 CLR 638 at [41], was that:
[M]odern pleadings have never imposed so rigid a framework that if evidence which raises fresh issues is admitted without objection at trial, the case is to be decided upon a basis which does not embrace the real controversy between the parties … cases are determined on the evidence, not the pleadings.
99 Much earlier, Muirhead J said in Caruso Australia Pty Ltd v Portec Australia Pty Ltd [1986] FCA 40, in a passage cited with approval by Davies J in National Australia Bank Ltd v Nobile (1988) 100 ALR 227 at 236:
The powers of this court to amend pursuant to Order 13 Rule 2 are more than wide, they tend to be remedial in that "all necessary amendments shall be made for the purpose of determining the real questions raised by or otherwise depending on the proceedings, or of correcting any defect or error in any proceeding, or of avoiding multiplicity of proceedings". Consideration of the authorities indicates that an amendment should only be refused where bad faith is demonstrated or where the consequential injury or prejudice to the other party is incapable of remedy. And this reasoning applies to amendments sought during trial or on the eve of trial.
100 In Leotta v Public Transport Commission (NSW) (1976) 9 ALR 437 at 446; 50 ALJR 666 at 668, Stephen, Mason and Jacobs JJ said:
If in the cause of action upon which the plaintiff sued there had emerged at the conclusion of the evidence facts which, if accepted, established that cause of action, then it was the duty of the trial judge to leave the issue of negligence to the jury. The pleadings should have been amended in order to make the facts alleged and the particulars of negligence precisely conform to the evidence which had emerged.
101 Similarly, in Water Board v Moustakas (1988) 180 CLR 491 at 497 Mason CJ, Wilson, Brennan and Dawson JJ said that if issues not apparent from the pleadings are litigated, the pleadings should be amended accordingly.
102 Secondly, the respondents contended that all the evidence to which the applicants pointed was available before the hearing began and before the Fourth Further Amended Statement of Claim was filed, before the close of evidence, and during the time the parties were preparing their written closing submissions. The applicants have had "ample time" to identify the issue and further amend their pleading without prejudicing the respondents.
103 It is quite true that the applicants have had a long time to identify the issue. They could have amended much earlier. In the light of what I have said, however, I find it difficult to believe that the respondents are prejudiced by the late amendment, apart from the fact that they might have made some further submissions directed to the specific point had the matter been included in the last iteration of the applicants' pleading. Any such prejudice is easily cured by granting leave conditional on the respondents being given the opportunity to make further submissions.
104 Thirdly, the respondents contended that granting leave "likely may cause an outcome inconsistent with the objects of Part IVA". They argued that in order to discharge their burden of proof the applicants need to establish by evidence what specialist surgeons knew at the relevant time. They contended that any evidentiary gaps concerning autoimmune diseases resulting from a grant of leave "necessitate findings in favour of the [r]espondents" and that would "work an injustice on prospective applicants".
105 I have already referred to the objects of Pt IVA. Once again, I struggle to see how these objects would be compromised, let alone undermined, by granting leave to make the proposed amendments. In any case it seems counter-intuitive, to say the least, to deny the applicants an application they wish to make on the ground that the evidence upon which they rely is insufficient to make out their case.
106 Finally, the respondents submitted that they were deprived of the opportunity to cross-examine Mrs Gill on her evidence that she would not have consented to implant surgery had she been told that the mesh was unsuitable for patients with an autoimmune disease like psoriasis. I do not accept this submission. The respondents had the opportunity. They simply chose not to avail themselves of it. Mrs Gill also gave evidence that she would not have undergone the surgery if she had been warned of other risks. She was not cross-examined about her evidence in these respects either, although these risks were expressly pleaded. During oral argument Ms Morgan said (at ts 6910) that she was "happy to accept if [she] put … to any of the applicants that they wouldn't have done it, they would have said -- they would have still done it. Each of them would have said, 'No, I wouldn't'". There is no reason to believe that the respondents' position would have been any different if the proposed "new" complication had been included in the pleading at the time.
107 Having given careful consideration to the points raised by both parties, I am not satisfied that the amendments would cause any injustice to the respondents.