Statute limitations extended where necessary in pelvic mesh case
Class action on behalf of women surgically implanted with synthetic mesh – Claims based on defective goods, misleading or deceptive conduct and negligence – Whether certain claims statute-barred, and if so, whether limitation periods can and should be extended – Applicants’ claims upheld – Limitation periods extended where necessary
This is a milestone decision in the Johnson & Johnson pelvic mesh class action. It follows the trial that ran from early July 2017 to the end of February 2018 and which involved 48 witnesses (including 37 experts) and the tendering of over 164,000 pages of evidence. As to be expected given the complexity of the proceeding and the volume of evidence, Katzmann J’s judgement is long and highly detailed, spanning almost 1,500 pages. This summary has been written following review of her Honour’s summary along with a select review of relevant sections of the judgment pertaining to Part IVA issues.
Nine specific mesh products (the devices) were the subject of the class action. The respondents were three companies in the Johnson & Johnson group: two “Ethicon” companies who developed and made the devices and Johnson & Johnson Medical Pty Ltd (JJM), the Australian promoter and distributor of the devices.
The class action was brought on behalf of an open class, being Australian women who, at any time prior to a certain date suffered complications after having the devices inserted to treat either stress urinary incontinence (SUI) or pelvic organ prolapse (POP). The devices used for SUI were inserted to support soft tissue to reduce or prevent leakage; the devices used for POP were inserted to stabilise the muscle and fascia of the pelvic floor. Although the devices served slightly different purposes, they were all permanently surgically inserted and the complications arising from their use were common. As at the commencement of the trial, some 700 women had registered as class members, although it was estimated that 90,000 devices were supplied in Australia during the relevant period, spanning more than two decades.
The Applicants’ Claims
The proceeding had three applicants, who brought seven claims – four statutory claims under the Trade Practices Act 1974 (Cth) (TPA) and the Australian Consumer Law (ACL) and three common law claims in negligence. The applicants claimed:
- The devices had a defect within the meaning of the TPA and the ACL and were not of merchantable quality or fit for their particular purpose.
- The information provided both to doctors and to patients did not warn of risks that the respondents knew or ought to have known and was misleading.
- The respondents did not take reasonable care to evaluate the safety of the devices once released to the market.
- The applicants were injured because of the defects and were entitled to compensation.
- The applicants were injured because of the contraventions by the respondents against legislation along with the respondents’ breaches of duty of care.
** Trigger Warning **
The findings show egregious and shocking conduct on the part of the respondents. They are confronting and troubling to read. Whilst these findings are included for the sake of completeness and context, readers may wish to skip to the section titled ‘Liability – statutory claims’ for discussion of the findings on liability and the relevant legal principles relating to Part IVA.
The Pleaded Complications
The applicants pleaded that the devices caused up to fifteen different, serious complications, about which the respondents provided inadequate or no warning. These complications included:
- chronic inflammation in the tissue surrounding (or attached to) the implants;
- chronic pain;
- pain during sex and/or avoidance of sex;
- difficulty urinating and defecating;
- urinary incontinence;
- damage to surrounding organs, nerves, ligaments, tissue and/or vasculature; and
- recurrence of prolapse.
It was pleaded that once the devices were implanted, they were difficult, if not impossible, to remove.
Primer – Biomaterials & The Meshes
Each of the devices were comprised of a biomaterial mesh. Her Honour explained that a biomaterial is considered to be ‘biocompatible’ where it serves its function with an appropriate host response in the part of the body in which it is inserted. Where a biomaterial is to be inserted permanently, it needs to maintain its integrity and not degrade in the body and should not have an adverse effect on the tissue and organs in the part of the body in which it is inserted. Simply because a biomaterial is apposite for use in one part of the body does not mean it will be so for use in other parts of the body.
The meshes are porous and are designed to allow human tissue to grow through them (much like a lattice). Once implanted, the mesh would cause an inflammatory response (a ‘foreign body reaction’) whereby scar tissue would form through and around the mesh. The applicants alleged that this reaction caused the mesh to contract which would lead to a number of complications.
The Evidence Re The Meshes
Her Honour’s summary examines at some length the evidence given by one of the respondents’ experts, Dr Hinoul, who was the Vice-President of Medical Affairs at Ethicon Inc. Under cross-examination Dr Hinoul admitted Ethicon knew:
- the devices would cause each of the pleaded complications;
- the mesh would be subject to a contracting force;
- there was a risk of the mesh breaking through or off into the vagina or organs, which could occur many years after implantation;
- all the devices could cause ‘life altering’ acute and chronic pain which could require multiple operations to fix;
- the mesh was difficult, if not impossible, to remove safely without complications, and in the case of one of the mesh products, attempting removal could be ‘disastrous’; and
- should complications occur, the original conditions (POP or SUI) could recur.
The meshes used in the devices were originally developed for use in treating hernias in the abdomen. In contrast, the pelvis is an area of the body which is subject to different forces and which was a much more sensitive region. The evidence showed that Ethicon was aware of these differences, such that the meshes may not have been appropriate for use in the pelvis. The evidence showed that Ethicon failed to consider these differences when developing the devices. The evidence also demonstrated that some of the devices had been launched with little or no supporting clinical evidence.
Primer – Regulatory Compliance
Another issue in the case was whether the devices complied with the relevant regulatory regime for medical devices in Australia. That regime has two aspects:
- Pre-launch – before a medical device can be supplied, it must be included on the Australian Register of Therapeutic Goods (ARTG).
- Post-launch – after it is launched to market, a medical device must be continually evaluated and reported on to confirm it remains appropriate for use and inclusion on the ARTG.
As to the requirements for launching a product, the process relies on the manufacturer justifying to the Therapeutic Goods Association (TGA) that the use of the medical device and that any risks associated with the product are outweighed by the benefits conferred by the device. In the case of the devices, this can be supported by the device containing the ‘CE’ mark, which represents that the device conforms to EU standards. This was the course adopted by the respondents in relation to the devices. Her Honour emphasised in her summary that medical devices “are largely self-regulating” and that in the case of the devices, all but one device were launched into Australia without independent assessment by the TGA.
The Evidence Re Regulatory Compliance
Her Honour noted that the “evidence revealed widespread and systematic non-compliance with regulatory requirements, standards and guidelines” (at p 14). In particular, it was found that none of the devices at any time satisfied the requirements for ‘CE’ marking, on which their inclusion on the ARTG was justified.
The evidence showed that Ethicon’s regulatory compliance in relation to the pre-launch assessment of the devices was poor for a number of reasons:
- As noted earlier, no or negligible clinical trials were conducted prior to launch and in particular no comparative trials involving a control population, such as a randomised control trial, were conducted.
- Key design and technical documents that manufacturers are required to create were not contained in Ethicon’s files.
- Ethicon had no organised risk management system and “[r]isk management assessments were largely treated as a box-ticking exercise” (at p 15).
- Inadequate clinical assessments were relied upon for ‘CE’ markings.
Ethicon was also found to be seriously lacking in compliance in relation to its post-launch obligations. The evidence showed:
- Post-market evaluation was “reactive, when it should have been proactive” (at p 16), with studies sponsored for marketing purposes rather than for genuine evaluation.
- No proper risk analysis was conducted post-launch.
- Post-launch evaluation reports were not regularly prepared as required. In the case of some of the devices, reports were not prepared for 5-10 years post-launch and in some cases, conclusory text was included in the reports that was copied and pasted from reports for other devices.
- Complaints from medical practitioners and patients were not properly dealt with and were not integrated into a risk management process.
- Ethicon were aware of the above failings, having been made aware by its auditors, the TGA and other regulators overseas.
Liability – Statutory Claims
Her Honour found that the instructions for use for the devices did not disclose the risk of the pleaded complications arising from, or the lack of clinical support for, the use of the devices. Her Honour also found that the evidence supported the finding that the materials published by the respondents doctors and patients was misleading in certain respects as risks were downplayed whilst the benefits of the devices were over-exaggerated. In some cases, amendments to instructions and marketing materials were not made until the TGA intervened in 2015 and then, even once amendments had been made, the materials remained insufficient and misleading. In one case, a device was marketed as being ‘specially designed’ for use in the pelvis, when the mesh had been originally designed for use in the abdomen.
Her Honour found that the devices all had a defect. In her summary, her Honour stated (at p 21)
Having regard to all the relevant circumstances … I was satisfied that at all relevant times all the Ethicon devices had a defect. It follows from the common position taken by the parties that at all such times all the Ethicon devices were also unfit for the particular purposes for which they were acquired and of unmerchantable quality… All the devices carried risks of complications the respondents admitted were clinically significant, against which no adequate warnings were given, and about which doctors and patients alike could have been misled. None of them satisfied all the essential requirements for CE marking. In essence, the Ethicon devices were oversold, that is to say, they were promoted to doctors as suitable for most patients when they had not been adequately evaluated, when they carried significant risks, and when the respondents had not provided sufficient guidance about the nature or extent of the risks, the management of those risks, or the patients who were most at risk.
Consequently, her Honour found that the respondents were liable in respect of the injuries suffered by the applicants arising from the defects. Her Honour also held that on the basis of the marketing and instruction material, the respondents had engaged in misleading or deceptive conduct.
Liability – Common Law Claims
The applicants were also successful on their claims in negligence. Her Honour held that the respondents owed duties of care in the supply and marketing of the devices (both pre- and post-launch) and in the case of Ethicon, an additional duty was owed in relation to the “design, testing and evaluation of the devices”. Unsurprisingly, given the evidence, her Honour found that the respondents had breached their duties of care in three respects, holding that there was inadequate:
- pre-launch assessment of the devices;
- post-launch assessment of the devices; and
- disclosure of risks associated with the devices, and that information regarding the devices’ safety and benefits was misleading.
Part IVA Matters
Her Honour’s reasons also touch on some Part IVA matters, albeit briefly. The respondents had argued that the three applicants were not able to represent all of the class members because they only had three of the nine devices implanted. This argument was swiftly rejected by her Honour, citing her decision in Philipsen v American Medical Systems LLC (No 2)  FCA 1580 and the Full Court’s decision in Ethicon Sàrl v Gill (2018) 264 FCR 394;  FCAFC 137 where it was held that “the regime [in Pt IVA] expressly contemplates and provides for the individuality of claims within group proceedings”.
Her Honour also cited Lee J’s decision in Dillon v RBS Group (Australia) Pty Ltd (2017) 252 FCR 150;  FCA 896 where his Honour held that ‘claim’ in the context of Part IVA is to be given a broad meaning.
Her Honour stated (at ): “[i]t is clear from the terms of s 33C(1) that, provided the conditions set out in paragraphs (a)-(c) are made out, one or more persons can represent all members of the group”.
Her Honour also examined the meaning of “sufficient interest” as used in s 33D, stating (at ): “The purpose of this provision is to overcome the common law rule in relation to standing which would prevent one person from suing another on behalf of a third person… Its effect is that, provided an applicant has standing to sue the respondents on her own behalf, she can bring a representative proceeding on behalf of others whose claims concern or arise out of the same, similar or related circumstances and give rise to a substantial common issue of law or fact.”
At  her Honour concluded:
It is common ground that seven or more women have claims against the respondents… Although there are some issues which only affect one or other of the applicants, or subsets of the group members and others which affect individual group members only, those claims give rise to substantial common issues of law and fact. As I pointed out in Philipsen at , “substantial” in this context merely means “real or of substance”… The fact that not all of the Ethicon devices were supplied to the applicants does not mean that they were ineligible to represent those women who had been supplied with the other devices.
Gill v Ethicon Sàrl (No 5)  FCA 1905
- Federal Court of Australia, Katzmann J, 21 November 2019
- Applicants’ Solicitors: Shine Lawyers;
- Respondents’ Solicitors: Clayton Utz;
- Applicants’ Funder: N/A
Read more about this case on Austlii: Gill v Ethicon Sàrl (No 5)  FCA 1905
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