Pelvic mesh, patient harm, consumer law & a clash of culture

PELVIC MESH, PATIENT HARM, CONSUMER LAW & A CLASH OF CULTURE: ETHICON SÀRL V GILL

JOEL GRIEGER, SESSIONAL TEACHERM ADELAIDE LAW SCHOOL; M.PHIL. CANDIDATE, UNIVERSITY OF ADELAIDE

Previously touted as Australia’s “largest women’s health class action,”1 the title is now official. The pelvic mesh proceedings against Johnson & Johnson subsidiaries have become Australia’s largest settlement for a product liability class action.2 Subject to Federal Court approval, a $300 million compensation settlement was reached in September 2022. Addressing two class action claims, it will hopefully provide some relief to the many women suffering life-altering complications from faulty medical devices.

From a legal perspective, these proceedings are particularly interesting as they combine different practice areas. Whilst pelvic mesh, surgical implantation, medical complications, and patient harm may be familiar terms in medical law or personal injury, less clear is their relevance to consumer law. Indeed though, this decision is part of an emerging body of cases applying consumer provisions to resolve medical disputes. It also exposes deeper issues of competing interests at the intersection of business and healthcare (commercial incentives v patient wellbeing). This results in a ‘clash of culture’, and exacerbated risk of patient harm.

Background

The settlement concerns the recent judgment of the Full Court of the Federal Court in Ethicon Sàrl v Gill (2021) (Ethicon v Gill), on appeal from Gill v Ethicon Sàrl (No 5) [2019] (Ethicon (5)).3 Ethicon (5) was a representative class action brought by three applicants (Applicants), all suffering complications caused by medical devices manufactured and sold by Ethicon Sàrl, Ethicon Inc. and Johnson & Johnson Medical Pty Ltd (together, ‘Ethicon’ – all subsidiaries of multinational pharmaceutical company Johnson & Johnson). The nine devices in question (being mesh or tape) were made of knitted polypropylene, surgically implanted to treat stress urinary incontinence or pelvic organ prolapse.

The pelvic devices were considered a new use of existing technology. The polypropylene material was initially developed for sutures, before adaptation to mesh for hernia treatment. As an existing technology the approval process was less rigorous, despite use in a different anatomical location (female pelvis, not abdomen), with different physiological requirements. At risk of simplification, this change in use – without appropriate testing or warnings – caused many of the complications associated with the devices. These included: chronic inflammatory reaction; extrusion or erosion of mesh into surrounding organs; infection; chronic pain; avoidance of sexual intercourse; difficulty voiding; offensive vaginal discharge; incontinence; damage to surrounding organs, nerves, ligaments, tissue, blood vessels; haemorrhage; and reoperation due to complications.4

The Applicants’ case was that the devices could cause these potentially serious complications, and that Ethicon: a) failed to undertake the necessary investigations to identify the risks and act; and b) failed to adequately disclose the risks that they were aware of.5 As the devices were designed to permanently embed into the surrounding tissue, subsequent removal often proved difficult or impossible.

The judicial process was hardly expeditious. This was despite Ethicon, out of necessity towards the end of trial, conceding that from the time the devices were first sold, Ethicon were aware of all complications. 6

Proceedings began in the Federal Court October 2012 and culminated in a lengthy seven-month trial (July 2017 to February 2018). The decision in Ethicon (5) (November 2019) favoured the Applicants for all claims. Ethicon appealed unsuccessfully to the Full Court (Ethicon v Gill, March 2021), and followed with a special leave application to the High Court. This was dismissed November 2021.

Meanwhile Shine Lawyers (the Applicants’ solicitors) filed an additional class action (April 2021), involving participants treated after 4 July 2017. They were ineligible for Ethicon (5) as their surgeries occurred after the trial commenced. The Federal Court ordered (April 2022), with consent of the parties, that a claims resolution process commence so compensation could begin. This settlement applies to both class actions.

It is still unknown how many group members will share in the settlement. At the start of Ethicon (5), 700 participants had registered. As it was an open action, more claimants have since joined. While awaiting Court approval, Shine Lawyers will continue assessing eligibility. Given approximately 90,000 relevant devices were sold in Australia, final numbers are expected in the thousands.

Claims

Pleadings in Ethicon (5) were framed within two different regimes: common law, and statutory. Liability was established in common law negligence. Ethicon owed the Applicants a duty of care. By failing to appropriately evaluate the devices (before or after release), nor properly informing the Applicants (or surgeons) of the inadequate evaluations about, and the risks of, the kinds of complications the Applicants later suffered, Ethicon failed to meet the expected standard of care.7 Causation needed to be satisfied individually, which the Applicants did.

Negligence is a ‘usual’ way of litigating medical disputes. The Applicants’ choice

of statutory claims however, from the Trade Practices Act 1974 (Cth) (TPA) and Schedule 2 to the Competition and Consumer Act 2010 (Cth), the Australian Consumer Law (ACL), are perhaps more ‘novel’. While ACL provisions were considered in Ethicon (5), it was the comparable TPA provisions primarily applied; most of the conduct occurred prior to 1 January 2011, when the TPA was in force.

While there are numerous differences between the statutes, they were predominantly inconsequential to Ethicon (5). 8 There are however wording variations between comparable provisions, including: ‘defect’ and ‘safety defect’; ‘merchantable quality’ and ‘acceptable quality’; and ‘particular purpose…made known’ and ‘disclosed purpose’.

Ethicon (as ‘manufacturers’)9 owed statutory duties to ‘consumers’ (‘individuals’ for defective goods claims), including the Applicants as patients. As all respondents carried on business in Australia, the provisions applied. This was despite two respondents being incorporated overseas, with no ‘place of business’ here.

Despite differing in nature from common law negligence, the same foundational question applies; did the Applicants suffer identifi able harm because of the act (or omission) of Ethicon? It was held that Ethicon breached all claimed provisions, as the devices and accompanying ‘Instructions For Use’ (IFUs) were of unacceptable quality. Although each provision contains multiple elements, for effi ciency this analysis limits identifi cation to the main points.

Defective goods

Ethicon contravened defective goods provisions,10 in that the devices had a defect, causing the complications.11 A ‘defect’ exists if device safety is not ‘such as persons generally are entitled to expect’;12 an objective standard13 considering surrounding circumstances, including: marketing, instructions, warnings, use of ‘marks’, and packaging. Essentially, what Ethicon said, or failed to say, about the devices. The defect does not need to affect everyone; devices could be defective even if only some people were affected.14

The Applicants did not purchase surgical mesh directly from Ethicon, nor make their choice alone, relying instead on advice from their treating surgeon. This however did not limit Ethicon’s duty to inform the Applicants of potential risks. That would contradict the legislation, designed to protect consumers; manufacturers are envisaged informing the learned intermediaries.15 Although how the duty is discharged may change, the obligation to warn does not.16

All devices had defects due to the nature and extent of the risks, the defi cient IFUs, how the devices were promoted, and the clinical evaluation shortcomings.17 There is a defence if, at the time of supply, the state of scientifi c or technical knowledge did not enable discovery of the defect.18 ‘Knowledge’ is not limited to the manufacturer, instead requiring that no-one could have reasonably discovered the defect at the time.19 Given Ethicon conceded knowing all risks prior to fi rst supply, this defence failed. Like negligence, clear connection between the act (or omission) and the harm is needed. This was satisfi ed for each of the Applicants.

Merchantable quality & fi tness for purpose

The devices were unfi t for purpose20 and lacked merchantable quality.21 For unfi tness for purpose, the Applicants mainly needed to show that: (1) when acquiring the devices, they did so for a particular purpose (made known to Ethicon); (2) the devices were not reasonably fi t for that purpose; and (3) the Applicant suffered loss or damage because of that.22

For ‘particular purpose’, precedent exists in some cases that a manufacturer may be presumed to know a consumer’s purpose,23 and that applied here. The Court also stated the TPA intended matters like this (goods commonly acquired for a particular purpose) to be covered by s 74D (merchantable quality), not s 74B (unfi t for purpose); it was unnecessary to bring claims in both.24 Whether the devices were fi t for the particular purpose was objective; what would a reasonable person in the Applicants’ position expect?25 It was up to Ethicon to demonstrate that the Applicants did not rely on the manufacturer’s skill and judgment.26

Unmerchantable quality on the other hand requires Applicants to prove: (1) the devices were not of merchantable quality; and (2) the Applicants suffered loss or damage because of this.27 This will be the case if the devices are not fi t for the purpose that goods of its kind are commonly bought (considering description, price and all other relevant circumstances). This is based on what could objectively be expected at the time of supply in the circumstances,28 and it may be enough to demonstrate risk of device failure, rather than proving actual failure.29 The Court found it reasonable to expect a device to not carry risks that were not disclosed.30

As the Applicants succeeded with the defective goods claim (s 75AD), the claims under ss 74B and 74D also succeeded,31 as each of the Applicants individually proved causation.32

Misleading or deceptive conduct

Ethicon’s actions breached the provisions protecting against misleading or deceptive conduct,33 as the devices were promoted in ways which failed to contain proper disclosures or warnings of the potential complications and their gravity. Despite noting several issues with the form of these pleadings, the Court found in favour of the Applicants, agreeing the behaviour was either misleading or likely to mislead.34

Why apply both Negligence & ACL?

So, why would a plaintiff complicate matters and initiate proceedings under both regimes? Beyond protection from one claim failing, it provides an increased range of remedies; the options are far broader with ACL claims compared to common law (in medical negligence, the primary remedy is damages).35 In Ethicon (5) the Applicants succeeded in all claims, each electing to receive damages pursuant to common law.36 Because the statutory claims were also successful though, some additional ACL remedies were available. While equitable remedies such as injunctions are possible, though rare, in common law, the ACL in contrast provides a suite of possible remedies. Depending on the cause of action, they include damages (s 236), adverse publicity orders (s 247), other compensatory orders (s 237) or pecuniary penalties (s 224), non-punitive orders including compliance programs (s 246), and a range of other orders as the court sees fit (s 243).

Further observations

Ethicon (5) displays the competing interests of business and healthcare – profit v patient wellbeing – and the risks that follow. There is a ‘clash of culture’ occurring at the intersection, repeatedly identified in medico-legal decisions involving patient harm, often resulting from commercial entities placing their interests before the patient.

It was the underlying systemic driver of behaviour in Ethicon (5), routinely prioritising commercial interests over patient safety. This affected many important decisions, from device development through to distribution. Rather than provide appropriate disclosure, patients were misled because Ethicon ‘did not consider it was in their commercial interests to be full and frank with the public about the risks associated with their products.’37 They were driven by their commercial interests and motivated by a ‘sales-driven culture,’38 reflected in the non-compliance with IFU standards.

The level of influence that Ethicon’s marketing department had in developing and wording the IFUs was troubling, given it is an important technical document. Greater concern was given to how the devices were perceived, rather than disclosing known risks. This caused the Court to ponder: ‘Why, I ask rhetorically, was this a matter for a marketing manager,’39 before resolving ‘[i]t is difficult to avoid the conclusion that marketing considerations prevailed to the potential detriment of patient safety.’40

When it next comes time to balance competing interests, Ethicon (5) provides: ‘persons generally are entitled to expect that commercial considerations are not prioritised over patient safety.’41 Healthcare providers should take note, and perhaps consider this a $300 million warning. B

Endnotes 1 Jerome Doraisamy, ‘High Court dismisses appeal in “largest women’s health class action in

Australia’s history”’, Lawyers Weekly (online, 5

November 2021), <https://www.lawyersweekly. com.au/biglaw/32952-high-court-dismissesappeal-in-largest-women-s-health-class-action-inaustralia-s-history>. 2 ‘Settlement Reached In Mesh Class Actions’, Shine

Lawyers (webpage) <https://www.shine.com.au/ media-centre/media-releases/settlement-reachedin-mesh-class-actions>. 3 The Ethicon decisions, particularly Ethicon (5) at 1,500 pages, are detailed and lengthy.

Comprehensive analysis of either is beyond the scope of this article, as are detailed analysis of the considerations of the Court for each pleading.

For further information, perhaps start with: Joel

Grieger, Mark Giancaspro and Bernadette Richards,

‘Consumer Law, Technology and Health Care: A Shift in Focus, a Panacea or a Confounder?’ (2020) 28 Journal of Law and Medicine 54; Michaela Estelle

Okninski and Joel Grieger, ‘Evolving Law: Further

Developments Concerning MAID in Canada-Bill

C-7 Receives Royal Assent and Revisiting Ethicon

Sàrl’ (2021) 18(3) Journal of Bioethical Inquiry 371-376. 4 Gill v Ethicon Sàrl (No 5) [2019] FCA 1905, [184] (‘Ethicon (5)’). 5 Ibid [5]. 6 Ibid [189]. 7 Ethicon Sàrl v Gill [2021] FCAFC 29, [6]; (2021) 387

ALR 494 (‘Ethicon v Gill’). 8 Ethicon (5) (n 4) [3115]. 9 See TPA s 74A; ACL s 7. 10 TPA s 75AD; ACL s 138. 11 Ethicon (5) (n 4) [3163]. 12 TPA s 75AC; ACL s 9. 13 Ethicon (5) (n 4) [3170]; Merck Sharp & Dohme (Australia) Pty Ltd v Peterson (2011) 196 FCR 145, [191] (‘Merck’); Carey-Hazell v Getz Bros & Co (Aust)

Pty Ltd [2004] FCA 853; (2004) ATPR 42-014, [186] (‘Carey-Hazell (2004)’). 14 Ethicon (5) (n 4) [3174]; Merck (n 13) [201]. 15 Ethicon (5) (n 4) [3218]. 16 Ibid [3223]. 17 Ibid [3413], [3458], [3496]-[3500]. 18 TPA s 75AK(1)(c); ACL s 142(c). 19 Ethicon (5) (n 4) [3504]; Merck (n 13) [204]. 20 TPA s 74B; ACL s 55. 21 TPA s 74D; ACL s 54. Note that ACL s 54 utilises the language of ‘acceptable quality’. 22 TPA s 74B; Ethicon (5) (n 4) [3519]. The ACL equivalent, which has some slight variances, is s 55. 23 Ethicon (5) (n 4) [3523]; Carey-Hazell (2004) (n 13) [212]; Merck (n 13) [171]. 24 Ethicon (5) (n 4) [3524]. 25 Ibid [3525]; Merck (n 13) [174]; Graham Barclay

Oysters Pty Ltd v Ryan (2000) 102 FCR 307, [533][536]. 26 Although initially raised as a defence by the respondents, it was later abandoned: Ethicon (5) (n 4) [3527]. 27 Ethicon (5) (n 4) [3528]-[3530]. 28 Medtel Pty Ltd v Courtney (2003) 130 FCR 182, [64] (‘Medtel’). 29 Ibid [72]-[74]. 30 Ethicon (5) (n 4) [3543]. 31 Ibid [3544]. 32 Ibid [4429], [4498]. 33 TPA s 52(1); ACL s 18. 34 Ethicon (5) (n 4) [3581], [3607]. 35 New South Wales v Stevens (2012) 82 NSWLR 106, 110 (McColl JA); [2012] NSWCA 415. 36 Gill v Ethicon Sàrl (No 6) [2020] FCA 279. 37 Ethicon (5) (n 4) [3318]. 38 Ibid [5]. 39 Ibid [3327]. 40 Ibid [3337]. 41 Ibid [3377].