5.4 Discussion
612 Grounds 1 and 2 of the appeal must be dismissed.
613 The first alleged error is that the primary judge's finding at TJ [1336] that none of the devices was safer or more effective than any of the alternative treatments is wrong and demonstrates her Honour's analytically flawed approach. The appellants alleged that in light of the inherently individual nature of the inquiry her Honour erred in making an assessment of safety and efficacy in these terms.
614 As we said in our overarching observations, while we accept that the appellants did not have to prove anything, this submission must be rejected.
615 First, at TJ [1336] the primary judge said only that none of the devices had been proven to be safer or more effective than the alternative available treatments for SUI and POP. Her Honour did not say that in all patients and in all circumstances alternative treatments, particularly native tissue repair surgery, were safer or more efficacious than implantation of one of the devices. We have no difficulty in accepting that one or more alternative treatment options might be unavailable to a particular patient because of her individual circumstances, nor that having regard to a patient's individual circumstances implantation of one of the devices may benefit the patient. But the primary judge did not say otherwise. Professor Roovers' evidence does not expose any error in her Honour's conclusion.
616 Second, the appellants said that the benefits of using the POP devices outweighed the risks for women with any level of prolapse. But mere disagreement with a finding does not establish error and there was ample evidence which supported her Honour's conclusion at TJ [1284]-[1335]. The appellants fell well short of establishing that her Honour erred in finding that none of the devices had been proven to be safer or more effective than the alternative available treatments, or in finding (at TJ [3496]) that the evidence did not support the conclusion that the benefits of using the POP devices outweighed the risks for women with any level of prolapse.
617 Third, we give little weight to the appellants' argument when, as the respondents submitted:
(1) the appellants decided to withdraw TVT Secur and the POP devices from the market because of the high failure rate of TVT Secur and rather than performing the post-market surveillance studies of the POP devices which the regulatory authorities required : TJ [2445], [2491], [2498], [2500];
(2) one of their witnesses, Associate Professor Rosamilia, gave evidence that the key long term study of the TVT products said to support the products' safety and efficacy was a poor review from which it was difficult to draw reliable conclusions: TJ [911]; and
(3) the primary judge's conclusion was reached having regard to Cochrane reviews which the appellants relied on to support their contention that synthetic suburethral slings such as the TVT products were equally or not materially less safe and effective than traditional laparoscopic colposuspension (TJ [1322]-[1336]), and the appellants did not identify any error in the primary judge's analysis of the Cochrane reviews.
618 Fourth, there is no substance in the appellants' contention that the primary judge approached the question of defect on the basis that they were required to "exhaustively demonstrate" that use of the devices would not cause a "certain frequency of certain kinds of complications", for decades before the devices could first be marketed. There is nothing in her Honour's findings to indicate that her Honour required that of the appellants. Dr Hinoul conceded that the appellants knew from the time the devices were first supplied anywhere in the world that they could cause the pleaded complications. Having regard to that, and the concession that each of the complications was clinically significant, her Honour decided that the devices presented a risk of harm about which the appellants provided no or no adequate warning. That, in combination with the other relevant circumstances to which her Honour referred, strongly supported the finding that the devices are defective. The other relevant circumstances included that: (a) none of the POP devices was the subject of an adequately powered clinical trial before it was released to market (TJ [3496]), (b) the appellants represented that the devices met the essential requirements for CE marking, which included adequate pre-market clinical evaluation, when they had not done so (TJ [3458], [3496]), and (c) an appropriate warning would have included any limitations of the available clinical data in relation to the devices (TJ [1336]). We can see no error in that approach.
619 The second alleged error is that the primary judge erred at TJ [4410] in failing to distinguish the remarks in Merck at [191]-[192].
620 In those paragraphs, in particular at [192], the Full Court concluded that in the context of a prescription drug, the relevant circumstances under s 75AC may include the product information and warnings provided to doctors and pharmacists by the manufacturer. The appellants did not challenge the Full Court's approach but argued that the present case is distinguishable because medical devices are unlike prescription drugs in that "the implants involve the further input of the surgeon with whom the patient elects to have the index surgery, including his or her preferences, training and capacity". Her Honour rejected that argument at TJ [4410], doing so on the basis that the prescription of drugs also required the input of the treating doctor including his or her preferences, training and capacity, and that the distinction proposed by the appellants was unwarranted.
621 We do not consider the primary judge erred as alleged and we can see no basis to distinguish the remarks in Merck on the facts of the present case. The role of a doctor in deciding whether to recommend use of a medical device (whether or not for implantation) is relevantly analogous to that of a doctor deciding whether to recommend use of a prescription drug. In both settings the manufacturer supplies the goods and any accompanying product information or instructions for use to the doctor, not to the patient. The goods will be used by the patient only upon receipt of medical advice and a recommendation, which can be expected to include an appropriate warning about any risks associated with the goods. In both settings the doctor is required to exercise medical expertise and professional judgment in providing medical advice and a recommendation, which can be expected to be tailored to the patient's individual circumstances and may in some circumstances take into account the doctor's personal preferences.
622 In any event, under s 75AC it is mandatory to consider "any instructions for, or warnings with respect to" the relevant goods, and thus to consider any information, advice or warning provided by the manufacturer to doctors. That is what her Honour did.
623 The third alleged error is that the primary judge misapplied the statutory test, as demonstrated at TJ [4401]. The appellants argued that the primary judge approached the statutory test by considering whether there was an adequate warning of a list of pleaded complications and then reasoning that each device would have a defect if there was any risk that was not disclosed.
624 The primary judge said the following (at TJ [4401]):
The role of a safety warning is to alert the consumer to the risks associated with the use of the product to protect her or him from harm. In the case of a medical device, warnings as to adverse events and contraindications, and advice as to the limits of the available information serve to assist patients to make an informed decision about whether to undergo surgery with such a device. Where a medical device, when used as intended, exposes consumers to a risk of significant harm, then the device will have a defect unless it is accompanied by warnings sufficient to alert patients to that risk. In such a case, the defect is not the absence or inadequacy of the warnings, as the respondents contended, but the fact that the device has a propensity to cause harm that persons generally would not reasonably expect.
(Emphasis added).
625 The appellants relied on the highlighted passage.
626 This submission has no merit.
627 First, contrary to the appellants' submissions, the primary judge recognised that ss 75AC and 75AD do not require that goods must be absolutely free from risk. So much is clear (at TJ [3191]) where her Honour said "[i]mportantly, the law does not require that goods be "absolutely free from risk"" citing Merck at [191].
628 It cannot be said that the primary judge approached the question of defect on the basis that the existence of any risk meant that the devices were defective when her Honour: (a) recognised that goods need not be absolutely free from risk, (b) recognised that all surgical treatments carried risks (e.g. TJ [60] and [130]), (c) referred to a "risk of significant harm" at TJ [4401], and (d) made numerous findings addressed to the incidence and severity of the pleaded complications. There is nothing in her Honour's reasons to suggest that she proceeded on the basis that the devices were defective if their implantation presented any risk, and there are many parts of the reasons which show to the contrary.
629 Second, the primary judge's remarks at TJ [4401] were made under the subheading "Causation under the Trade Practices Act". At TJ [4398] her Honour set out a statement in Merck at [104] that to establish causation "a plaintiff must establish as a necessary condition of recovery that he or she would not have suffered loss but for the defendant's actionable misconduct". At TJ [4399] her Honour said:
…the [appellants] argued that if there were a defect then it comprised the absence of suitable warnings in that the [respondents] needed to prove that the loss or damage was caused by the absence of warnings. The [respondents], on the other hand, argued that the defect was the risk of harm posed by the goods, not the absence of a warning.
In the following paragraph (TJ [4400]) her Honour remarked, in relation to causation, that everything turned on how the defect is properly characterised.
630 It is in that context that the remarks at TJ [4401] must be understood. They were directed to the rejection of the appellants' argument on causation, not to the statutory test in relation to defect. To the extent that there is some looseness of language in her Honour's remarks at TJ [4401] it is not material to the finding of defect, which was not made in that paragraph and instead made earlier in her Honour's reasons at TJ [3458], [3496] and [3499]. As we explain below those paragraphs of the reasons reveal no error. As we later explain in dealing with causation, the primary judge's statements of principle about causation for statutory defect are immaterial because she found, in fact, that the injuries suffered by each of the representative respondents were caused by the defects in the relevant devices.
631 Third, the primary judge correctly applied the statutory test, doing so by reference to the decision in Merck. Her Honour said the following (at TJ [3172]-[3175]):
[3172] …Since the question of whether there is a defect requires consideration of the way goods are marketed and instructions or warnings that have been given with respect to their use, the expectations persons generally are entitled to have about the goods will be affected by what the manufacturer has said about them. Thus, even if a product presents certain risks, that product may well not have a defect if the manufacturer gives appropriate warnings about those risks, defines appropriate limitations on the indications for use, and does not promise more in terms of safety than the product can deliver. The applicants conceded as much. The instructions or warnings mentioned in s 75AC(2)(d) relate to the doing or refraining from doing something with, or in relation to, the goods. In the present case that would encompass instructions or warnings about use in relation to pregnant women or women of child-bearing years, for example, or about implantation in certain other kinds of patients. It would ordinarily not encompass warnings or advice about potential adverse effects. Nevertheless, it was common ground and properly so, consistent with the judgments in Peterson v Merck Sharpe & Dohme (Aust) Pty Ltd (2010) 184 FCR 1 (Jessup J) and on appeal in Merck (together, the Vioxx case), that information or warnings given by a manufacturer about the potential adverse effects of the use of a product are also relevant since they could affect the level of safety that persons generally are entitled to expect.
[3173] Naturally enough, the defect must exist in the particular goods that are alleged to have caused injury to the individual: Peterson at [912]. Consequently, the applicants must prove that the particular Ethicon devices had such a defect.
[3174] It has been clear at least since the Vioxx case that a product may be defective even if the defect is one which only affects some people. In endorsing the primary judge's decision that Vioxx had a defect within the meaning of s 75AC, the Full Court in Merck at [201] described the defect in this way:
The defect was one which affected some people, not all. The defect was that in some people, by a mechanism not known and the subject of no hypothesis, it increased the risk of [myocardial infarction] and provided no information, advice or warning as to this effect.
[3175] It also follows from Merck that the risk need not be high, although the extent of the risk posed by the product which will render a product defective may vary from case to case. The relevant risk in that case was very low (0.5% risk of myocardial infarction) but the potential consequences were grave, indeed fatal.
632 Her Honour also said at TJ [3188]:
In Carey-Hazell (2004), a case about an allegedly defective prosthetic mitral valve, Kiefel J (as her Honour then was) observed at [199] that without a warning or instruction the use of a product might be unsafe and a warning is necessary to remove "some inherent dangerous quality". In Peterson, Jessup J held at [915]-[918] that the safety of the drug was less than persons generally were entitled to expect because the consumption of the drug had the potential to increase the risk of myocardial infarction in circumstances which included the absence of any relevant information or warning from the manufacturer.
633 Consistently with the approach in Merck, the primary judge evaluated the risk of the pleaded complications. Her Honour did so against the background that:
(1) Dr Hinoul conceded that from the time each of the devices was first supplied anywhere in the world the appellants knew of the potential of the devices to cause each of the pleaded complications: TJ [189]-[191], [3200];
(2) the appellants conceded that each of the pleaded complications was clinically significant: TJ [191], [1134];
(3) any "attempt to distil the evidence into a neat summary of incidence rates would be riddled with potential pitfalls" and it was unnecessary to do so because of the appellants' concession that each of the pleaded complications was clinically significant, and that they would not take any issue as to the precise incidence of the complications: TJ [1134]; and
(4) the weight of the evidence indicated that the use of mesh caused complications of a kind, degree or rate different from or greater than those associated with traditional forms of pelvic floor repair: TJ [199].
634 Having regard to the pitfalls in distilling the evidence into a neat summary of incidence rates (TJ 1134), and given the appellants' concessions, it was unnecessary for the primary judge to make evidentiary findings in relation to the incidence of the pleaded complications. Nevertheless her Honour referred to a "snapshot" of the evidence which showed the prevalence of the pleaded complications (TJ [1137], see also TJ [1143]-[1283]) and made numerous findings, including that:
(1) pain and dyspareunia can be both more severe and more enduring after repair procedures involving the use of mesh than after traditional prolapse surgery: TJ [228];
(2) the severe chronic and intractable pain that can occur after mesh surgery was virtually non-existent or not encountered after native tissue repair: TJ [233], [236];
(3) chronic pain was common (1-10% of cases) after implantation of SUI devices: TJ [1139], [1167];
(4) to the extent there was evidence of chronic pain after native tissue SUI repair, such pain was treatable: TJ [1168];
(5) dyspareunia and apareunia were likely to be common after implantation of the POP devices: TJ [1234];
(6) erosion is a serious adverse event in the case of SUI devices when surgical intervention is required (TJ [1143]) and the reported rate of erosion across the studies was around 2 to 5%: TJ [1144];
(7) erosion is common to all of the SUI devices: TJ [1151]; and
(8) erosion rates in POP devices was around 10 to 12% (TJ [1208]) and is at least common after transvaginal implantation of any and all of the POP devices: TJ [1216].
635 The primary judge's reasons are replete with examples which show that she understood that in determining the extent of the safety of the devices under s 75AC the Court is required to consider "all relevant circumstances": e.g. TJ [3165], [3171], [3191]. It is plain from the reasons that her Honour's consideration did not involve simply comparing the list of pleaded complications against the warnings provided by the appellants. This can be readily seen at:
(1) TJ [3458], where the primary judge held that at all material times all the SUI devices had a defect having regard to the following relevant matters:
(a) the nature and extent of the risks associated with the devices;
(b) the deficiencies of the Ethicon's warnings and the other information they provided;
(c) the repeated failure to comply with the requirements for CE marking; and
(d) the way in which the devices were marketed; and
(2) TJ [3496] and [3499], where the primary judge held that at all material times the POP devices and Gynemesh PS had a defect having regard to the following relevant matters:
(a) each of them exposed women to significant risks of injury;
(b) against which risks inadequate warnings were given and in respect of which misleading representations were made including that:
(i) Ethicon was not candid with the public about the risks of and contraindications for use of the devices or the limitations of the available data; and
(ii) Ethicon represented that the benefits of using the POP devices outweighed the risks for women with any level of prolapse when the evidence did not support that;
(c) none of the POP devices was the subject of an adequately powered clinical trial before it was released to market;
(d) Ethicon represented that the devices met the essential requirements for CE marking when the material upon which they relied to affix and maintain the CE Mark was insufficient to satisfy those requirements;
(e) Gynemesh PS was defective because:
(i) its implantation exposed women to the risk of significant injury;
(ii) the warnings given by Ethicon were insufficient to protect users from those risks;
(iii) the information supplied with and about the device was liable to lull users into a false sense of security; and
(iv) the limitation made to the indication for use for the device (which came into effect on 16 March 2013) might have lessened the complication rate but the product was still defective, because the information accompanying the device was still insufficient to put users on notice of the true nature and extent of the risks.
636 The primary judge also had regard to the following relevant circumstances:
(1) the purpose of the devices is to treat SUI and POP, neither of which is a life-threatening condition and treatment, including surgery, is elective: TJ [3369];
(2) the use of the devices involved permanent implantation in the female pelvis: TJ [3369];
(3) even if surgery is chosen, there are well-established and well accepted alternative forms of surgical treatment that do not involve the use of mesh : TJ [3369]; and
(4) the POP devices were promoted as safe and effective treatments first-line treatments for pelvic organ prolapse: TJ [3466].
637 Her Honour approved Dr Elliott's remark in a 2012 article (Elliot D, "Con: mesh in vaginal surgery: do the risks outweigh the benefits?" (2012) 22 Curr Opin Urol 2012 276-281 at 280 (SHI.MESH.00033536 at 3540)) where he said, in relation to transvaginal mesh kits for prolapse repair, that "[i]t is one thing to have a high complication rate when dealing with life or death issues without suitable alternatives - in this situation a complication, even a severe one, may be acceptable when a patient has no other choice and his or her life is at stake"; it is another where the patient has a choice and her life is not in danger: TJ [3369].
638 Fourth, as we have said, there is no substance to the appellants' contention that the primary judge ignored the critical question whether having regard to: (a) the risks associated with the devices, (b) the totality of the warnings and other information (including the knowledge of treating pelvic surgeons), and (c) the nature of the implants as medical devices (which includes their relative benefits), the safety of the devices is not such as persons generally are entitled to expect.
639 It is plain from her Honour's reasons that she considered each of those matters. Given the comprehensiveness of her Honour's reasons as previously summarised, and that we have previously dealt with some of these matters it is not necessary to set out all the ways in which this contention can be shown to have no proper basis. It suffices to note the following.
640 In relation to "the risks associated with the Ethicon devices" the primary judge's reasons are replete with her consideration of the evidence concerning that issue, and her findings, including:
(1) in Part IV (TJ [183]-[298]) under the heading "the risks posed by the Ethicon devices", in which her Honour noted Dr Hinoul's concession that at all material times the appellants knew of the potential of each of the devices to cause the pleaded complications and the appellants' concession that each of the pleaded complications was clinically significant. Her Honour also made findings as to the nature of the pleaded complications and the circumstances which they arise;
(2) in Part V (TJ [299]-[787]) under the heading "[b]iocompatibility issues" her Honour made findings regarding the problems associated with the biocompatibility of polypropylene mesh implanted in human tissue. Amongst other things, her Honour accepted the evidence of Professors Klosterhalfen and Klinge that implantation of the devices gave rise to a risk of chronic inflammation, infection, erosion, contraction and chronic pain: TJ [788]; and
(3) in Part VI (TJ [788]-[1336]) under the heading "[t]he performance of the devices" her Honour evaluated the weight to be given to the conclusions of the various medical or scientific studies upon which the parties relied, made findings including as to the incidence and severity of the complications caused by pelvic mesh, and considered the comparative benefits and risks of the devices as against traditional native tissue repair surgery. Her Honour found that none the devices had been proven to be safer or more efficacious than other alternative treatments in the long-term.
641 Her Honour also gave detailed consideration to the evidence and made findings regarding "the totality of the warnings and other information" including:
(1) Dr Hinoul gave evidence that: (a) the IFUs accompanying the devices represented Ethicon's official statement as to what it said were the adverse reactions associated with the products (TJ [2584]), (b) a doctor would be entitled to expect that the company supplying the product would have access to more knowledge about its product than others in the medical community (TJ [2584]), (c) the IFU was an important document from Ethicon's point of view to ensure that the user of its devices had a means to know exactly what Ethicon regarded as the risk associated with the device, and (d) it was important for all risks associated with the implantation of the device to be included in the IFU;
(2) since the commencement of the Medical Devices Regulations on 4 October 2002, there has been an unqualified statutory obligation to provide certain information with any medical device including "[a]ny warnings, restrictions, or precautions that should be taken, in relation to use of the device" and IFUs were required to include "[a]ny contra-indications, warnings, restrictions, or precautions that may apply in relation to use of the device" and "[f]or an implantable medical device - information about any risks associated with its implantation: TJ [3840] and [3841];
(3) the contents of the IFUs for the SUI devices at TJ [2586]-[2628] and the POP devices: TJ [2629]-[2655];
(4) the interventions by the US, Canadian and Australian regulators which led to some late, but in her Honour's view, inadequate improvements in the warnings provided in the IFUs: TJ [2656]-[2681];
(5) the training the appellants provided to surgeons in relation to operations to implant the devices, finding that the training was not provided to all surgeons and was insufficient to adequately equip those who received it with the skills and information to conduct the operations with minimal risk of injury: TJ [2682]-[2705]; and
(6) the appellants' marketing of the devices (TJ [2708]-[2809]) including through product brochures for patients and for surgeons for the SUI devices (TJ [2719]-[2758]) and for the POP devices: TJ [2759]-[2797].
642 Her Honour made detailed findings regarding the inadequacy of the appellants' warnings and other information provided about the risk of the pleaded complications associated with the SUI devices (TJ [2814]-[2939]) and the POP devices: TJ [2940]-[3028]. She accepted Dr Pence's evidence that at the time of her report the IFUs for the SUI devices were deficient (TJ [2622]-[2628]) as were the IFUs for the POP devices: TJ [2645]-[2655]. Having regard to other evidence and Dr Hinoul's testimony that from the time each of the devices was first supplied anywhere in the world Ethicon knew of their potential to cause the pleaded complications, her Honour concluded that warnings of the pleaded complications should have been provided with the devices from the time that each was made available for sale: TJ [2628], [2655]. Her Honour found that at all material times the warnings and other information provided by the appellants about all the devices were deficient: TJ [3029]-[3034].
643 In relation to "the knowledge of treating pelvic surgeons", we have previously set out her Honour's discussion of the evidence and her inference that treating pelvic surgeons in general were not aware of the risk of the pleaded complications. As previously explained, we are not persuaded that her Honour erred in that regard. Further, in our view the finding accords with the weight of the evidence.
644 In relation to "the nature of the implants as medical devices (which includes their relative benefits)" it was uncontroversial that the devices were intended and used for permanent implantation in the pelvis of women suffering either from SUI or POP. It was also uncontentious that these are complex medical conditions for which a variety of different treatment options are available, and the selection of the appropriate treatment option will depend on the individual circumstances of the patient. Against that background, one of the matters the primary judge considered was the comparative risks-benefits of traditional native tissue repair surgery as against repair using one of the devices. It is unnecessary to go to every finding in that regard and it suffices to note the following findings:
(1) all surgical treatment options for POP are associated with risks, but that complications from native tissue repair are generally short-lived and treatable: TJ [130];
(2) the weight of the evidence indicates that the use of mesh causes complications of a kind, degree or rate different from or greater than those associated with traditional methods of pelvic floor repair, which complications cannot wholly be explained by insufficient surgical training or experience. Other factors, including product design, mesh porosity, the quantity of mesh used, the route and methods of implantation and patient-specific factors cause or contribute to the development of adverse reactions following the implantation of synthetic mesh, including the various devices: TJ [199];
(3) pain can be both more severe and more enduring after repair with procedures involving the use of mesh than after procedures which do not: TJ [228];
(4) in contrast with native tissue repair, pain after mesh surgery can arise well after surgery including many years later: TJ [216], [232];
(5) removal of the mesh which may be required in cases of mesh exposure, extrusion, erosion, chronic pain, or recurrent prolapse, (which does not arise in native tissue repair) presented additional problems, and the mesh is difficult, if not impossible, to remove entirely as it is or becomes integrated in the connective tissue, and that removal surgery may not relieve pain: TJ [244] and [246];
(6) it was appropriate to accept the evidence of Professor Korda who said that polypropylene mesh implants carried a risk of certain complications that were unknown to pelvic surgeons versed in native tissue repair. He said that severe, chronic and intractable pain that can occur after mesh surgery was "virtually non-existent" after native tissue repair (TJ [233]) and that "complications such as mesh erosion, mesh contracture, bunching, severe chronic pelvic pain, severe dyspareunia and pain on movement, sitting, standing were not seen before the introduction of mesh surgery": TJ [3235]; and
(7) her Honour was not satisfied on the evidence that at any time after each of the SUI and POP devices were first supplied in Australia that the devices were proven to be safer or more effective in the long-term than the alternative treatments: TJ [1336].
645 This is not to reject the proposition that for many women the devices had benefits. We can accept that for many, perhaps a majority of women, the devices proved to be an effective treatment of the SUI or POP they suffered. But the appellants' contention as to the benefits of the devices failed to engage with the fact that a fundamental mater underpinning the findings of defect is that each of the devices presented a risk of causing the pleaded complications in any woman implanted with a device, against which risk the appellants provided no or no adequate warning. In combination with the other relevant circumstances her Honour relied on, the devices were found to have a defect because they presented a risk of injury through the pleaded complications and the appellants failed to provide any or any sufficient warning in relation to that risk. The fact that the risk only eventuated in some women implanted with the devices, rather than all women, does not mean that the devices have the safety persons generally are entitled to expect: Merck at [201].
646 Fifth, as we said in our overarching observations, we are not persuaded that her Honour was mistaken in treating the patient brochures as a relevant circumstance under s 75AC when there was no evidence that a representative respondent or any group member had seen such brochures. The patient brochures were not central to the finding of defect and it was open to the primary judge to infer that the appellants produced the patient brochures intending that they should be given to surgeons and seen by patients: TJ [3267]. The brochures are relevant to the appellants' views about the state of knowledge of pelvic surgeons and of patients generally regarding the risks associated with the devices. Having regard to their contents, the brochures tend to show that the appellants did not believe that pelvic surgeons or patients generally knew about the pleaded complications. It can be accepted that warnings provided to patients through such brochures may be different in type, pitch and complexity to those provided to treating surgeons but that is beside the point. As the Full Court said in answer to common question 20 in Merck, where goods present a risk of harm, "[i]n the absence of any information, advice or warning addressed to a particular group member or to his or her medical practitioner" to the effect that use of the goods presents a risk of harm, particularly serious harm, goods may have a defect.
647 The fourth alleged error is that in determining the extent of the safety of the devices the primary judge did not properly consider and failed properly to take account of the significance of the evidence of the pelvic surgeons in relation to clinical considerations and the different safety profiles of each of the devices, together with their safety profiles relative to other surgical and non-surgical alternatives. It is said that the primary judge erred by failing to find that the evidence of pelvic surgeons should be preferred to the evidence of non-clinical experts, including the epidemiologists, biostatisticians, biomaterials experts and pathologists.
648 We do not accept that the primary judge erred as alleged.
649 First, as the respondents submitted, the appellants' argument seeks to sidestep the statutory question. A product has a defect within the meaning of s 75AC if its safety is "not such as persons generally are entitled to expect". Persons generally are entitled to expect that medical devices supplied to doctors and hospitals and not directly to patients, do not present a risk of injury, particularly significant injury, of which the manufacturer gives no or no sufficient warning. Persons are generally entitled to expect that the manufacturer will provide appropriate warnings to medical practitioners and/or directly to patients in respect of such risks.
650 Her Honour said at TJ [3376], and we agree that:
…where a medical device carries risks when used as intended, persons generally are entitled to expect that the manufacturer would provide medical practitioners with the information and warnings necessary to enable them to make a balanced, cautious, and informed judgment about whether to recommend implantation with one or other of the devices to their patients and to enable patients to make a balanced, cautions, and informed decision about whether to consent to such a procedure. That includes information about known and foreseeable risks. It includes information about those patients who are particularly at risk. It includes information about the true state of affairs, including the real risks of implantation with the device, the extent of the risks in the short and the long-term, and the limitations, if any, of the available data. Persons generally are entitled to expect that manufacturers are not selective about which risks or other information to disclose.
651 We accept the appellants' contention that the treating pelvic surgeons of women suffering SUI or POP played a key role in providing individualised medical advice and recommendations to them in relation to their treatment options, including in respect to the implantation of a device. It was those surgeons who were provided with the IFUs. They were obliged to apply their medical expertise and professional judgment in recommending the appropriate treatment options. As part of obtaining the patient's informed consent to the treatment they could be expected to provide appropriate warnings to their patients in respect of any risk of harm associated with the treatment options to which a reasonable person in the patient's position would attach significance. However, the fact that the treating pelvic surgeons occupied this key role does not address the statutory question and does not show the primary judge erred in finding that the devices were defective. Indeed, the fact that the treating surgeons occupied this critical role only serves to underscore the importance of the appellants providing frank and candid warnings to the surgeons as to the risk of the pleaded complications presented by the devices. Dr Hinoul conceded that from the time each of the devices was first supplied anywhere in the world Ethicon knew of its potential to cause the pleaded complications. Absent sufficient warnings from the appellants it would be left to chance that a particular treating surgeon would, in fact, know about the risk of the pleaded complications. That is not the extent of safety persons generally are entitled to expect.
652 Second, the asserted error is based in an assumption that at all material times the cohort of treating pelvic surgeons were aware of the risk of the pleaded complications associated with implantation of the devices, and could be expected to bring that knowledge to bear in recommending the implantation of an device. The appellants submitted that there was no requirement for them to warn surgeons of risks of which they were already aware, and they contended that it could never been the case that pelvic surgeons assumed that the appellants' IFUs carried a complete statement of all the risks associated with implantation of the devices.
653 However, as we have explained, that is contrary to the primary judge's inference that pelvic surgeons did not know of the risk of all the pleaded complications: TJ [3228]-[3248]. It is also contrary to the finding, amongst others, that:
(1) the IFUs were important to surgeons as a statement of the manufacturer's knowledge of the risks of the devices which meant that it was important that all risks associated with the implantation of the devices must be included in the IFUs: TJ [3315], [3371]-[3373];
(2) it was appropriate to accept Dr Pence's evidence that the manufacturer will know more about the risks associated with the use of their products than surgeons and that they are obliged to disclose what they know in the instructions for use: [TJ 2580]; and
(3) an average reasonably competent pelvic surgeon would expect the manufacturer to provide [the surgeon] with information about the use, surgical technique, risks of adverse events, and studies supporting safety and efficacy: TJ [3249].
654 Further, as we have also previously noted, each of the pelvic surgeons who gave evidence is a highly credentialed, trained, experienced, clinical professor with a research interest in mesh surgery, and both individually and as a cohort their knowledge must have materially exceeded that of pelvic surgeons in general. Even so, the evidence shows that their understanding of the risks associated with implantation of the SUI and POP devices developed over time through experience, research and engagement with injured patients. It also must be kept in mind that the relevant time for determining whether each of the devices has a defect is when each of them came onto the market: TJ [3169]. That is also the time when Dr Hinoul said Ethicon was aware of the potential for each device to cause the pleaded complications.
655 Once it is understood that pelvic surgeons in general did not know about the pleaded complications at any material time, the manifest weakness of the appellants' contention that the primary judge erred by failing to give proper regard to the evidence of pelvic surgeons is apparent. The appellants submitted that the requisite warning was one which was sufficient to permit treating pelvic surgeons with the necessary clinical experience and expertise properly to engage with their patient and obtain informed consent in relation to implantation of a device. However, as previously discussed, a treating pelvic surgeon could not make a properly informed judgment in deciding between the available treatment options, nor properly engage with his or her patient in obtaining informed consent to implantation of a device, if the surgeon was not aware of the risk of the pleaded complications associated with the device.
656 It is clear on the evidence that:
(1) as Dr Hinoul conceded in cross-examination, at all material times the appellants knew that implantation of all of the devices presented a risk that one or more of the pleaded complications might arise;
(2) as the appellants conceded, each of the pleaded complications was clinically significant;
(3) the devices and accompanying IFUs were supplied to doctor and hospitals, not directly to patients;
(4) at all material times treating pelvic surgeons in general were not aware of the risk of the pleaded complications;
(5) it was therefore necessary for the appellants to provide treating surgeons with sufficient information, advice and warnings about the pleaded complications to allow them to make a balanced, cautious, and informed judgment about whether to recommend implantation of a devices and to enable their patients to make a balanced, cautious, and informed decision about whether to consent to such a procedure: TJ [3376]; and
(6) the warnings and other information the appellants provided treating surgeons about those risks were seriously inadequate: see in relation to the SUI devices (TJ [2812]-[2839]) and in relation to the POP devices (TJ [2940]-[3028]).
657 In combination with the other relevant circumstances to which the primary judge referred at TJ [3458], [3496] and [3499], the fact that at all material times the devices presented a risk of harm through the pleaded complications, and that the appellants provided no or no adequate information, advice or warnings in relation to that risk, meant that at all material times the devices were defective.
658 Third, the asserted error is based in the contention that the primary judge failed properly to consider certain evidence which established that, when viewed in the context of clinical considerations, the benefit-risk profile for each device was such as persons generally were entitled to expect. The appellants relied on the following matters at AS [30]:
(a) The statements of multiple professional organisations indicating that midurethral slings (which include the SUI Implants) are the "operation of choice" (RANZCOG in March 2014 [ETH.MESH.16308855 at .16308856] and May 2017 [PUB.MESH.00009294 at .00009296] and IUGA in July 2014 [PUB.MESH.00001813]) or the "gold standard of care" (AUGS in March 2013 [SHI.MESH.00003903 at .00003905] and in 2014 [ETH.MESH.14481429 at .14481429]). In making these observations, these professional organisations indicated that the major advantage of the mid-urethral sling is that it has lower rates of complications when compared to other more invasive traditional surgery (RANZCOG 'Position statement on midurethral slings' (March 2014) [ETH.MESH.16308855 at .16308856]; AUGS 'Position Statement on Mesh Midurethral Slings for Stress Urinary Incontinence' (2014) [ETH.MESH.14481429 at .14481430], International Urogynaecological Association, 'Position Statement on Mid-Urethral Slings for Stress Urinary Incontinence' (July 2014) [PUB.MESH.00001813]).
These statements were criticised by the primary judge, largely on epidemiological grounds (TJ, [2511]-[2515]). As set out above, epidemiologists are not in a position to judge what is clinically (as distinct from statistically) significant.
(b) Abdominal sacrocolpopexy (which includes the use of mesh (and, specifically, was one purpose for which Gynemesh PS was used)) was described as the "Gold Standard" for addressing vault POP (Korda 1, p.73 [EXP.010.078.0001_3 at .0075_3]; Collinet 1, pp.28, 31 [EXP.020.005.0001_4 at .0028_4, .0031_4]).
(c) The fact that the Ethicon Devices are, in a high percentage of cases, effective and, in many cases, have lesser occurrence of other events, such as hospital stay and wound morbidity (and can be complication free).
(d) It is the pelvic surgeons who have the role of assessing the appropriate treatments and their relative safety and efficacy for their individual patients, together with the application of their knowledge in tailoring the informed consent discussions with individual patients (as explained above).
(e) The fact that no Australian treating surgeon gave evidence that the products were unsafe or should be taken off the market. Professor Blaivas (an American pelvic surgeon called by the Representative Applicants) indicated that it was not his position that the SUI Implants should be taken off the market (T723.15-17 [TRA.500.008.0001_2 at .0112_2]). Professor Korda accepted that mesh could be used in circumstances where the natural tissues are so compromised that they cannot be used to effect a repair and noted that it will be up to the individual surgeon to determine whether the tissues of a particular patient are so compromised (T1253.01-14 [TRA.500.015.0001_2 at .0036_2]). Implicit in this statement is the rejection of the proposition that the complication profile - the safety - of mesh repair is not what persons generally are entitled to expect. The primary judge seemed to overlook the fact that Professor Korda did not suggest that no doctor should treat POP using transvaginal mesh. If the safety of the Ethicon Devices is not what persons are generally entitled to expect, the pelvic surgeon experts called by the Representative Applicants would have given evidence to that effect. They did not. The evidence was the opposite: some treating surgeons use it, some use it in some circumstances, some do not use it. By way of example, Professor Korda continues to use the TVT-O (T1197.14-21 [TRA.500.014.0001_2 at .0069_2]).
(f) Midurethral slings (which included the SUI Devices) are the most studied treatment for female SUI and were the least invasive surgical option to treat SUI (T711.40-712.08 [TRA.500.008.0001_2 at .0100-.0101]).
(g) Professor Korda indicated that minimally invasive sub-urethral sling procedures (which included the SUI Devices) are the "gold standard" surgical treatment for urodynamic stress incontinence (T1211.03-18 [TRA.500.014.0001_2 at .0084_2]. They are used "almost solely" by gynaecologists and urologists (Collinet 1, p.32[EXP.020.005.0001_4 at .0032_4]).
(h) Although a vaginal sling operation (which included the SUI Devices) carries a number of graft-related complications, it is the standard of care in Prof Deprest's centre (Deprest 1, [109] [EXP.020.006.0001_4 at .0023_4 - .0024_4]).
(i) Professor Blaivas agreed that merely because an operation has the possibility of complications in due course does not mean it is not safe and efficacious (T601.38 -T602.05 [TRA.500.007.0001_2 at .0093 - .0094]).
(j) Professor Roovers opined that he had no doubt that mid-urethral slings are the surgical treatment of first choice for SUI (Roovers 1, pp.6-7 [EXP.020.033.0001_4 at .0008_4 -.0009_4]).
659 We have previously dealt with some of this evidence in dealing with the appellants' overarching contentions and it is again worth noting that the appellants' use of these parts of the evidence is highly selective, and reflects their attempt to conduct the appeal only on the basis of the parts of the evidence which suit them. That is impermissible. In any event, this evidence does not show that the primary judge erred in finding that the devices were defective The weight of the evidence strongly supports her Honour's finding that at all material times each of the devices had a defect under s 75AC.
660 As the respondents submitted, none of the evidence referred to by the appellants engaged with a fundamental matter underpinning the finding of defect, being that at all material times implantation of each of the devices presented a material risk of harm against which the appellants provided no or no sufficient warning.
661 The statutory test is an objective one as to the safety "persons generally are entitled to expect". Merck (at [201]) stands for the proposition that goods may have a defect because they present a risk of injury and the manufacturer fails to provide any or any sufficient information, advice or warning in relation to that risk. But goods that present a risk of harm may nevertheless not be defective under s 75AC, if the manufacturer provides appropriate information, advice or warnings about that risk. Merck does not suggest that a product which presents a material risk of harm cannot remain on the market or even be a product of choice for a medical practitioner, provided that the risk of harm is the subject of an appropriate warning by the manufacturer. Thus, it does not address the statutory test that some pelvic surgeons gave evidence, or that relevant professional organisations made statements, that a particular device is the "gold standard" or the preferred method of treatment, that the device continues to be used by surgeons, or that the device has advantages in comparison to alternative treatment options: see AS [30(a), (b), (f), (g), (h), (j)].
662 Turning specifically to some of the other matters raised by the appellants in AS [30]:
(1) in relation to AS [30(a)], the introduction of a discussion of complications, including chronic pain, is the notable difference between the 2014 and 2017 RANZCOG position statements on midurethral slings. As we have said above, the stark differences between the two documents shows that knowledge of a number of the pleaded complications emerged over time and very late in the life of the devices. The decision of RANZCOG to re-issue the statement in 2017 to introduce a discussion of risks such as chronic pain tends to show that the organisation did not consider those risks to be well known at that point, and therefore not well-known when the 2014 position statement was made. As the respondents submitted, other statements as to the benefits of mid-urethral slings by professional organisations similarly do not advance the appellants' position (particularly those omitted from AS [30], such as IUGA's expert report of 2015 which rejected the proposition that polypropylene is suitable for vaginal use without consideration of other materials because there was neither translational nor clinical evidence to support that view: SHI.MESH.00045854). For the reasons previously explained, we can see no force in the criticism that epidemiologists are not in a position to judge what is clinically as distinct from statistically significant. As we have said, the primary judge did not err in finding that the evidence of the epidemiologists, biostatisticians, biomaterials experts and pathologists had utility, and in using it for the purposes that her Honour did;
(2) in relation to AS [30(c)], it may be accepted that for many women the devices proved effective and may have given rise to a lesser occurrence of other events such as hospital stay and wound morbidity compared to native tissue repair surgery, and that in many cases implantation of the devices can be complication free. The proposition that this is so in a "high" percentage of cases need not be debated. But even assuming that is the case, it does not show error in the finding of defect. The respondents were not required to show that the risk to safety associated with the devices affected all persons who were implanted with them (although the evidence did show that the pleaded complications could be suffered by every woman implanted with one of the devices: TJ [405]). It is sufficient to show that the defect affects some people: Merck at [201]. That in a high percentage of cases the devices are effective does not preclude a finding of defect. In Merck Vioxx was found to present a 0.5% increased risk of myocardial infarction, and in the absence of a warning that was held sufficient to constitute a defect. In the present case a number of the pleaded complications were found to be "common" (1% to 10%) on the scale used by the Royal College of Obstetricians and Gynaecologists (TJ [808]) and no adequate warning was provided;
(3) in relation to AS [30(d)], as we have said, we have no difficulty in accepting that treating pelvic surgeons of women suffering SUI or POP played a key role in providing individualised medical advice and recommendations to them, and in obtaining their informed consent to implantation of a device. But that only serves to underscore the importance of the appellants warning the surgeons of the potential for each of the devices to cause all of the pleaded complications, which Dr Hinoul conceded the appellants were aware of from the time the devices were first supplied anywhere in the world, and which complications the appellants conceded were clinically significant;
(4) in relation to AS [30(e)], there was evidence that Australian surgeons considered the POP devices had no justification for use and the SUI devices should be used in far more limited circumstances and subject to far more extensive warnings than the appellants provided. In any event, the appellants' proposition does not show error in the finding that the devices have a defect. It may, of course, be relevant evidence that some treating surgeons do not consider a particular device to be unsafe, or that some treating surgeons wish to continue to use the device. But the statutory test is an objective one as to the safety "persons generally are entitled to expect" having regard to all relevant circumstances. To establish the devices were defective the respondents did not need to adduce evidence from surgeons that the devices were unsafe or should be taken off the market. Safety is a relative concept, and although goods present a risk of injury they may nevertheless not have a defect if the manufacturer provides appropriate information, advice or warnings about that risk. Again, the appellants failed to properly engage with the fact that a fundamental matter underpinning the finding of defect was that at all relevant times implantation of each of the devices presented a risk of harm through the pleaded complications, against which risk the appellants provided no or no sufficient warning; and
(5) the same can be said in relation to AS [30(i)]. We have no difficulty in accepting that merely because an operation involves the possibility of complications does not mean it is not safe and efficacious. In this argument the appellants again failed to engage with a fundamental matter underpinning the findings of defect, being their failure to provide any or any adequate warning in relation to material risks presented by the devices of which they were aware.
663 The fifth alleged error is that the primary judge erred in converting the concession by senior counsel for the appellants of potential clinical significance to a finding of certainty of clinical significance, as shown at TJ [189]-[191]. This is said to have led the primary judge into error as there are a number of pleaded complications where no finding was made, or could be made on the evidence as to their incidence and severity.
664 As previously discussed, this submission is without foundation. The appellants conceded in clear terms each of the pleaded complications is clinically significant having regard to, first, the incidence of each complication and, second, the consequence of each complication if it came to pass (except for those limited occasions where the appellants said there was some relevant consideration of significance which would be specifically identified to her Honour). In relation to incidence, senior counsel said that the appellants would not take any issue with the precise rates of complication associated with each device. In relation to consequence, senior counsel for the appellants acknowledged that this was part of the concept of clinical significance and was subject to the concession. For the reasons earlier given, the appellants' Annexure C is misconceived. Given the appellants' concessions, it was unnecessary for the primary judge to make evidentiary findings in relation to the incidence of the pleaded complications. Nevertheless her Honour referred to a "snapshot" of the evidence (TJ [1137]) and made some limited findings. There is no error in that. Otherwise, the appellants' reference to evidence of some of the pleaded complications being minor (bladder perforation and mesh erosion), as already discussed, is also confounded by other considerations: (a) the evidence is selective, (b) the references to the evidence fail to identify other findings of the primary judge to the contrary, and (c) the contention fails to recognise that the pleaded complications involve a risk which is material for every woman considering implantation with one of the devices. The materiality of the risk is not affected by the fact that the occurrence of the risk in any individual woman may involve a lesser degree of seriousness of injury.
665 The sixth alleged error is that the primary judge did not properly consider and failed properly to take account of the significance of the evidence as to the differences between each of the devices, as outlined in the appellants' Annexure B.
666 We accept that there are differences between each of the devices, including the method of implantation and the quantities of mesh, and that the type of mesh used in POP devices differed. It may also be accepted that there is a basis in the evidence for concluding that there is a relationship between the size or amount of the mesh used and the likelihood of complications, as the primary judge said at TJ [825].
667 The fact remains, however, that the appellants conceded in relation to each of the devices that each of the pleaded complications was clinically significant in terms of incidence and severity. They said that they would not take up any issue as to the precise rate of incidence of any complication: TJ [1134]. In those circumstances it was not necessary for the primary judge to make findings about the incidence and severity of each pleaded complication for each device; any difference in the incidence and severity of complications between the different devices was subsumed by the concession.
668 The seventh alleged error is based on appeal ground two, in respect of which the respondents filed a notice of contention. The appellants submitted that in finding that each device had a defect the primary judge erred in relying on, or placing too much weight on, conclusions of non-compliance with the requirements of CE marking. They contended that there was no suggestion either by way of pleading or submission that the CE Mark by itself, or by way of representation, formed a basis for finding that the devices were defective, and the respondents should have been held to their pleading.
669 This ground of appeal must also be rejected.
670 It can be accepted that the 5FASOC did not plead that the devices had a defect based on the CE Mark or any representation said to be made by the CE Mark. The closest the pleading came is at [26(b)] and [61] where it was alleged that the safety of the POP devices and the SUI devices respectively was not such as persons generally were entitled to expect because, amongst other things, prior to the supply of the devices in Australia the appellants did not undertake any, or any adequate, clinical or other evaluation of the risks and effectiveness of the devices, including their long-term risks and effectiveness (called the Mesh Evaluation Matters and the Tape Evaluation Matters). We note that the primary judge's conclusion that a CE Mark should not have been applied to the devices was to a significant extent based in a finding that the appellants' failed to conduct any appropriate clinical trials before releasing the devices to the market.
671 It was uncontentious below that the devices received regulatory approval in Australia based on the strength of the CE marking. In opening at trial, the appellants' senior counsel informed the Court that registration of the devices in Australia "piggybacks off the CE authorisation", confirming that "if a device is good enough for the European community, it's good enough" for Australian regulatory purposes. The appellants said the same in written opening submissions. That reflected the fact that the essential principles in the Medical Devices Regulations in Australia were harmonised with international standards established by a Global Harmonisation Task Force (GHTF): TJ [1371]. The European Essential Requirements are substantially identical to the Australian essential principles: TJ [1404]-[1405]. Once a manufacturer has declared - by CE Mark - that their product complies with the European Essential Requirements, the product is permitted to be recorded on the ARTG. The system is, in substance, self-regulating: TJ [1408].
672 Although it was not pleaded, the controversy between the parties included a claim advanced by the respondents that the devices carried a CE Mark, which they should not have as the appellants had not, in fact, complied with the requirements and standards to obtain the CE Mark, which was relevant to the question of defect.
673 First, whether or not it was pleaded, the primary judge was obliged to consider the CE Mark. Section 75AC(2)(c) provides that in determining the extent of the safety of the relevant goods "the use of any mark in relation to" the goods is a mandatory consideration. Each of the devices carried the CE Mark and the primary judge was required to take that into account in deciding whether the devices had a defect.
674 Second, a product is defective under s 75AC if its safety is less than persons generally are entitled to expect having regard to "all relevant circumstances". As the primary judge said at TJ [1342], one matter that will have a bearing on the safety expectations of the public at large is whether the devices satisfied relevant regulatory requirements and standards. Persons generally are entitled to expect that medical devices have, in fact, satisfied all regulatory requirements and standards which apply to their supply in Australia. In the circumstances of the present case it should have been plain to the appellants that the evidence of the respondents' regulatory experts as to the appellants' failure to comply with the requirements and standards for obtaining and retaining the CE Mark on each of the devices, and thus obtaining and retaining Australian regulatory approval, would be a relevant consideration for the Court under s 75AC.
675 Third, the respondents pleaded that the devices had a defect but did not raise the CE Mark. In the circumstances of the case we are not persuaded that their failure to plead that the existence of the CE Mark was a relevant circumstance in relation to defect means that issue was not before the Court for consideration. It plainly was in issue given the evidence and the course of the forensic contest.
676 The appellants were on notice that the respondents' regulatory experts would give evidence that, in a regulatory system which, in substance, depended on the manufacturer's own certification that it had met the requirements and standards for a CE Mark, the appellants should not have so certified, because they had not met the requirements. Having regard to the respondents' regulatory experts' evidence the appellants must have understood that part of the respondents' case was that the appellants had insufficient clinical evidence to apply the CE Mark to the devices, and thus to obtain regulatory approval to market the devices in Australia. They must therefore have understood that the application of the CE Mark to the devices was a relevant circumstance under s 75AC in deciding whether the safety of the devices was such as persons generally were entitled to expect.
677 It is noteworthy that although the appellants submitted that the respondents should be held to their pleading, they did not contend that they were taken by surprise, nor that they suffered any prejudice. In our view they could not do so when in written opening submissions at trial the respondents said (at [41]):
The regulatory evidence will establish that the [appellants] did not have adequate clinical evidence to support CE Marking of its Implants, did not adequately justify its reliance on existing clinical data, and should have conducted clinical investigative studies.
678 The respondents in written opening submissions also said (at [42]-[45]) that following the release of the devices onto the market, the appellants should have but did not conduct post-market clinical follow-up studies for the devices, should have but did not have in place proactive post-market surveillance programs which included post-market clinical follow-up studies, should have but did not have effective procedures for systematic review information received by it, of the scientific literature, and for the active collection of information relevant to the devices. Further, despite the fact any complaints should have been the subject of close analysis by the appellants, the evidence indicated that mishandling of complaints was not rare and the appellants' systems allowed "unconfirmed" reports to be discounted and therefore not analysed, even when injury was reported.
679 Under the heading "[w]ere the Implants defective?" the respondents said in opening (at [109]):
In their haste to get the Implants to market and sold as quickly and profitably as possible, the [appellants] made inadequate efforts to evaluate the safety of the Implants, or to give proper warnings about them … They also failed to keep up-to-date with advances in knowledge after the product went to market.
680 Those submissions were supported by expert evidence filed by the respondents in advance of the hearing. For example:
(1) Dr Allman, a clinical biochemist from the United Kingdom, had extensive relevant experience in regulatory affairs, having had a 30 year career in the medical device industry. His responsibilities included achieving or remedying compliance with the European medical devices directives, implementing processes for post-market surveillance, managing relationships with notified bodies, and advising on European clinical evaluation and investigation requirements: TJ [1348]. In his first report dated 8 September 2016, he said that, although Ethicon had procedures in place that were intended to meet regulatory requirements for obtaining CE marking for each of the devices, it did not in fact have adequate clinical evidence and did not have sufficient justification to affix a CE Mark to any of them. He concluded that Ethicon did not comply with the steps that a reasonable manufacturer would undertake to ensure that it was appropriate for the devices to maintain their CE marking once released onto the market: TJ [1480]; and
(2) Ms Holland, a biomechanical engineer and quality assurance consultant from the United States, had some 30 years' experience in regulatory compliance, quality systems development, auditing, and regulatory affairs in the medical device industry. She regularly analysed the design control and risk management processes and documentation of medical device manufacturers to identify their strengths and weaknesses and to evaluate whether the documentation complies with industry standards and practices. She also regularly examined their quality processes to determine operational effectiveness and compliance with regulations applying in the United States and the European Union: TJ [1349]-[1350]. In her report dated 24 August 2016 she was highly critical of Ethicon's approach to quality assurance and risk management. She said that Ethicon did not adhere at any time to EU or US industry requirements and regulatory standards in any of the following areas: design validation, evaluation of complaints, and management responsibility or risk management. She also said that during the development of both the SUI and the POP devices, no overarching, cohesive risk management system was in place. She described Ethicon's design validation process as flawed because it did not adequately represent the population of surgeons using the devices and feedback from surgeons was not fully evaluated or implemented: TJ [1501].
681 The appellants joined issue with the merits of the respondents' regulatory evidence in their written opening submissions at trial: at [63]-[68]. They submitted that "[t]he evidence of the [respondents'] regulatory and Quality Assurance experts overstates the requirements for pre- and post-market assessment of the Implants." They argued that their certification for the CE Marks "followed audits of the relevant design and risk assessment documentation for each Implant to confirm compliance with the applicable international standards". They said that Ethicon:
…appropriately relied upon its prior knowledge of the risks associated with Prolene sutures and mesh in conducting its risk assessments, and applied the design controls and risk mitigations in place for existing mesh products and Implants to new versions of the Implants, which is entirely consistent with clinical practice and the intent of the standards.
They submitted that "[m]aintenance of the CE Markings (and ARTG inclusion) for the Implants has involved ongoing clinical reviews, post-market surveillance and complaint monitoring": at [64]-[68].
682 In written closing submissions at trial (chapter 2, [47]) in a section headed "[l]egal issues common to each claim", the appellants described the evidence of the respondents' regulatory experts as "of no assistance to the Court" and "of peripheral relevance". Those submissions only make sense if the appellants understood that the controversy before the Court included the respondents' claim that the devices carried a CE Mark, which they should not have as the appellants had not, in fact, complied with the requirements and standards to obtain the CE Mark, which was relevant to the question of defect.
683 Her Honour rejected the appellants' contention that the evidence of the respondents' regulatory experts was not relevant at TJ [1356]-[1358], including because the evidence disclosed that the regulatory system is largely dependent on the manufacturer being frank with the regulators.
684 The primary judge also rejected the appellants' contention that the evidence of the respondents' regulatory experts was of little assistance because the respondents did not plead that or how the foreign regulatory environment informed the appellants' obligations: TJ [1359]. Her Honour rejected that contention on two bases, first, that the relationship between the European and the Australian regulatory regimes was not a matter that needed to be pleaded. It was a matter for evidence. Second, Dr Beech gave unchallenged evidence that the Australian system is very similar to the European system and that Australia accepts European certification: TJ [1360]-[1362].
685 It is clear from her Honour's reasons that she considered the evidence of the appellants' regulatory non-compliance to be relevant to both the statutory and the common law claims. At TJ [1360] her Honour rejected the appellants' contention that the evidence of the respondents' regulatory experts went outside the pleading. The appellants have not challenged the primary judge's finding at TJ [1360] nor explained why it was wrong.
686 Her Honour went on to say (at TJ [1363]):
Each of Dr Allman, Ms Holland and Dr Pence was well-qualified in the field. Each had extensive relevant experience and an in-depth understanding of the regulatory requirements. Each presented as a conscientious and careful witness exhibiting no hint of partisanship. Each easily withstood cross-examination. The respondents' submissions largely ignored their evidence. Neither in writing nor orally did they engage with it. Indeed, their submissions did not even mention the witnesses' criticisms of their conduct. Instead, as I observed earlier, they tried to marginalise the evidence. This strategy might have been a convenient way to sideline evidence that was potentially very damaging. But it was a risky one. And it did not succeed.
Her Honour concluded, in effect, that the appellants made a forensic choice not to adduce evidence in response to the respondents' expert evidence regarding the appellants' non-compliance with the requirements and standards to obtain and retain the CE Mark: TJ [1338].
687 In Banque Commerciale SA en Liquidation v Akhil Holdings Ltd [1990] HCA 11; (1990) 169 CLR 279 at 296, Dawson J said, as cited with approval in Vale v Sutherland [2009] HCA 26; (2009) 237 CLR 638 at [41]:
But modern 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.
688 To similar effect, in Betfair Pty Ltd v Racing New South Wales and Anor [2010] FCAFC 133; (2010) 189 FCR 356 at [51]-[53], [55]-[58] the Full Court explained that at trial a party is entitled to have the opposing party confined to that party's pleadings, but if the first party does not seek to so confine the opposing party but allows the other party to raise other material facts and issues for the determination of the Court, then the Court is permitted and possibly obliged to decide the proceeding on the further material facts and issues raised and addressed at trial. The Full Court said (at [52]-[53]):
Pleadings are a means to an end and not an end in themselves (Banque Commerciale per Dawson J at 292-3). As early as 1916 Isaacs and Rich JJ said, in Gould and Birbeck and Bacon v Mount Oxide Mines Ltd (in Liquidation) (1916) 22 CLR 490 (at 517):
Undoubtedly, as a general rule of fair play, and one resting on the fundamental principle that no man ought to be put to loss without having a proper opportunity of meeting the case against him, pleadings should state with sufficient clearness the case of the party whose averments they are. That is their function. Their function is discharged when the case is presented with reasonable clearness. Any want of clearness can be cured by amendment or particulars. But pleadings are only a means to an end, and if the parties in fighting their legal battles choose to restrict them, or to enlarge them, or to disregard them and meet each other on issues fairly fought out, it is impossible for either of them to hark back to the pleadings and treat them as governing the area of contest.
(Emphasis added).
Approached in these terms, the question is whether the respondents knew the nature of the case they had to meet.
689 Their Honours further explained (at [55]):
The course of proceedings is in the control of the Court. That control is to be exercised for the attainment of a just outcome. There will obviously be cases where a pleaded case does not raise an important fact for attention. If that remains the position at the end of the case, the case may be lost on that basis, so far as it depends on that fact. Sometimes it would be unfair to allow a party to amend a case, or a pleading, to raise a new matter which could have been, but was not, raised earlier. On the other hand, mere infelicity of drafting will rarely be allowed to defeat a case on its merits if the merits of the case have been made apparent on the evidence without unfairness to the other party.
(Emphasis added).
690 The evidence of the respondents' regulatory experts formed part of the "real controversy" between the parties. The appellants knew that their devices carried the CE Mark and must have known that "the use of any mark in relation to" the goods is a mandatory relevant circumstance under s 75AC. They knew that the case they faced included a claim that they did not have adequate clinical evidence to support their application of the CE Mark to the devices, and thereby their obtaining Australian regulatory approval. They must have known that resolution of the question whether their certification that the devices met the requirements and standards for applying the CE Mark was reasonable or appropriate may be a relevant circumstance under s 75AC.
691 Fourth, in relation to the appellants' other contentions, it is far from central that the primary judge had no evidence as to any Australian surgeon's or patient's understanding or appreciation of the CE Mark or as to what surgeons' knew about the path to regulatory clearance for medical devices: TJ [3250].
692 This is a curious submission. The IFUs for the devices (using Gynemesh PS and TVT as examples) expressly stated:
CE Mark: Product conforms to the essential requirements of the Medical Device Directive 93/42/EEC.
The appellants thereby represented to treating surgeons that they had complied with a directive that required them to inform users of all residual risks associated with the device (that is, risks which cannot be eliminated or protected against). Having done so, however, they now argue that the primary judge should not have taken that into account as a relevant circumstance under s 75AC.
693 The statutory test is an objective one as to the safety that persons generally are entitled to expect, not what surgeons or patients actually expected. Irrespective of what surgeons or patients actually understood from the CE Mark, the fact that the appellants made this representation is plainly a relevant circumstance for consideration under s 75AC.
694 The primary judge was obliged to decide whether the safety of the devices was such as persons generally were entitled to expect having regard to the presence of the CE Mark in relation to the devices and the evidence of the respondents' regulatory experts that, in fact, the appellants did not comply with the requirements and standards to apply CE Marks to the devices. It was mandatory for the Court to take that evidence into account.
695 We are not persuaded that the primary judge erred as alleged under appeal ground 2.
696 But even if we are wrong in that view, it is not material to the result in the appeal. The fundamental matter underpinning the primary judge's finding of defect was the conclusion that at all material times implantation of the devices presented a risk of harm through the pleaded complications, against which risk the appellants failed to provide any or any adequate warning. That finding was challenged in the appeal but in in our view no error was established. Having regard to that and to the other relevant circumstances under s 75AC to which her Honour referred at TJ [3458], [3496], [3499], if her Honour's findings based on the appellants' non-compliance with the requirements for CE marking were erroneous, there nevertheless remains a strong and sufficient basis for concluding that each of the devices was defective.