Publications

Pelvic Mesh Litigation – Outcome of the Federal Court of Australia Trial in Gill v Ethicon Sàrl (No 5)

Published on August 18, 2020 by Bill Madden

As first published in the Australian Health Law Bulletin, July 2020 edition, pp 53-58

This note reports on the first instance decision of Katzmann J (Federal Court of Australia) in a representative (or class) action brought by three women, each of whom suffered complications after surgery involving the transvaginal implantation of synthetic mesh devices. Five of the devices were indicated for use as surgical implants for women with stress urinary incontinence and four for use as surgical implants for women with pelvic organ prolapse.

Background

Although some media reports focused on the potential number of women who may be able to seek compensation following the decision of the trial judge Katzmann J in Gill v Ethicon Sàrl (No 5) [2019] FCA 1905; BC201910541,¹ as a representative action there were only three claimants in the proceedings: Kathryn Gill, Diane Dawson and Ann Sanders, each of whom suffered complications after surgery. Their claims followed a number of legal pathways, most but not all of which succeeded.

The claimants brought their claims not only for their own benefit, but also on behalf of an unknown number of Australian women in similar positions who suffered complications following the transvaginal implantation of tapes or synthetic mesh.² As long as certain conditions are satisfied, a person may bring a claim on behalf of others who have different claims.³ At the beginning of the trial, about 700 women had registered as group members. There were multiple amendments to the group definition over the course of the proceedings.⁴ However, as more than 90,000 of the respondents’ devices have been supplied in Australia, more women may seek to make claims.

The Respondents

The action was brought against three related companies, all members of the Johnson & Johnson group. Ethicon Sàrl, is a Swiss corporation, and was the manufacturer of all but one of the devices in question. Ethicon Inc is an American corporation and was the manufacturer of another Ethicon device, Gynemesh PS, and was involved in marketing all the relevant devices.⁵ Ethicon Sàrl and Ethicon Inc supplied the Ethicon devices to Johnson & Johnson Medical Pty Ltd (JJM), an Australian company, which promoted and supplied the Ethicon devices to Australian doctors and hospitals. The three respondents denied liability and the action was vigorously defended.

The Devices

The devices considered in the litigation fell into two categories. Firstly, for the treatment of stress incontinence, there were various forms of tension-free vaginal tape (TVT).⁶ The tapes were designed to be inserted between the middle of the urethra and the skin of the vagina to provide support for damaged or weakened muscles and ligaments and reduce, if not stop, leakage. Secondly, for the treatment of pelvic organ prolapse, there were various forms of mesh. The purpose of these devices was to provide reinforcement and long-lasting stabilisation of the fascial structures of the pelvic floor.⁷

The Australian Register of Therapeutic Goods

The trial judge noted that the law seeks to protect people from harm that can be caused by medical devices. No medical device can be sold in Australia unless it has been approved by the Therapeutic Goods Administration (TGA) for inclusion on the Australian Register of Therapeutic Goods (ARTG).⁸ To secure inclusion on the ARTG for the Ethicon devices, JJM (as the Australian company supplying the goods) relied on the fact that the devices carried a “CE” mark, signifying that they had been cleared for sale in the European Union. “CE” is an acronym for the French words for European conformity. When the Ethicon devices were entered in the ARTG, all but one class of device that had received CE marking were accepted for registration without the TGA conducting any independent assessment of their safety or efficacy and without the need for the manufacturer to demonstrate that independent pre-market testing of their safety and efficacy had been carried out.

The Pleadings

The applicants brought seven claims, four under Commonwealth consumer protection laws and three at common law in negligence. Numerous issues were
raised. Some were common to the applicants and some or all members of the group they represented. Others were unique to the individual applicants. The impugned conduct giving rise to the claims took place over more than two decades. During this period, different laws applied at different times and there were also some
geographic legislative variations (Western Australia, Victoria).

There are two broad options which might permit users of medical devices to obtain compensation:

• Commonwealth legislation, being the Trade Practices Act 1974 (Cth) and, since 2010, the Australian Consumer Law, which is part of the Competition and Consumer Act 2010 (Cth), both contain pro-visions making corporations that supply goods that they manufacture liable to compensate people who are injured because of defects in those goods, because the goods are not fit for the particular purpose for which they are acquired, or because they are not of merchantable quality. “Goods” include medical devices. “Manufacturer” has an extended meaning under the legislation. Relevantly it includes corporations who import goods into Australia. It was not in dispute that JJM was a manufacturer for the purposes of the Act. The legislation also prohibits corporations from engaging in misleading or deceptive conduct about the attributes of their goods.
• The common law imposes on manufacturers and in some cases suppliers, duties to consumers of their goods to take reasonable care for their safety and allows people to sue for damages if they are injured because of a breach of such a duty. This is the cause of action in negligence.

The applicants argued that they suffered injury and were entitled to compensation because:

• All of the Ethicon devices had a defect within the meaning of that term in the Trade Practices Act and none was fit for the particular purpose for which it was acquired or of merchantable quality.
• The information provided by the respondents in the instructions for use supplied with the devices and in promotional material they disseminated did not warn of certain risks of which the respondents knew or ought to have known and, in numerous respects, was misleading because of those omissions and because of false statements and half-truths contained in the documentation.
• The respondents failed to take reasonable care to evaluate the safety of the Ethicon devices both before and after they were taken to market.

The Findings

In a lengthy judgment running to almost 1500 pages,⁹ the trial judge found in favour of the three applicants in most respects, making five key findings:

1. All of the Ethicon devices had a defect within the meaning of that term in the Trade Practices Act and none was fit for the particular purpose for which it was acquired or of merchantable quality.¹⁰ The Trade Practices Act provided that goods have a defect if their safety is “not such as persons generally are entitled to expect”. Except for the addition of the word “safety” before “defect”, the relevant provision of the Australian Consumer Law is identical.¹¹
2. The information provided by the respondents in the instructions for use supplied with the devices and in promotional material they disseminated did not warn of certain risks of which the respondents knew or ought to have known and, in numerous respects, was misleading because of those omissions and because of false statements and half-truths contained in the documentation. The pleaded risks included a chronic inflammatory reaction, extrusion or erosion of the mesh into surrounding organs, infection, chronic pain and other issues.¹²
3. The respondents failed to take reasonable care to evaluate the safety of the Ethicon devices both before and after they were taken to market.
4. The applicants were injured because of the defect in the devices the respondents supplied to them and were therefore entitled to compensation.
5. The applicants were also injured because of the other contraventions of the legislation and the breaches by the respondents of their duties of care, and were therefore entitled to damages.

The evidence established that the pre-market evaluation of the devices undertaken by Ethicon was deficient, as was the post-market surveillance.¹³
The trial judge did note, however, that the respondents were not oblivious to the importance of patient safety.¹⁴ They knew that doctors and patients wanted to be assured that their products were both safe and effective. They introduced changes to their devices which they believed or hoped would reduce the risk of injury. However, they continued to promote and sell the older devices after the new and “improved” versions were introduced and they remained publicly coy about what they knew and did not know about all of them.¹⁵

In determining whether a product has a defect, in that its safety is less than persons generally are entitled to expect, all relevant circumstances must be taken into account. It has been clear, at least since the Vioxx case¹⁶ that a product may be defective even if the defect is one which only affects some people.¹⁷ The Trade Practices Act stipulates that those circumstances include: the manner in which, and the purposes for which, the goods have been marketed; their packaging; the use of any mark in relation to them; any instructions for, or warnings with respect to doing, or refraining from doing, anything in relation to them; what might reason- ably be expected to be done with, or in relation to, them; and the time when they were supplied by the manufacturers.¹⁸ In relation to the defect allegations, the trial judge found that at all relevant times, all the Ethicon devices had a defect. The relevant goods were marketed as safe and effective in the treatment of the conditions for which they were indicated. Risks were minimised or not mentioned at all. The use of the CE mark constituted a representation that the Ethicon devices met the requirements for CE marking and that the manufacturers had taken the necessary steps to enable them to apply the mark. It followed from that finding (as the parties agreed) that at all such times, the Ethicon devices were also unfit for the particular purposes for which they were acquired and of unmerchantable quality. The trial judge rejected the statutory defence pleaded by the respondents that the state of scientific or technical knowledge at the time the Ethicon devices were supplied was not such as to enable the defects to be discovered. While the evidence showed that with the passage of time there was an increase in knowledge about certain matters, the respondents did not prove that the knowledge that was available at the relevant times was not such as to enable the defects to be discovered. Indeed, before any of the devices were supplied, the respondents were admittedly aware of the relevant risks.¹⁹ In relation to the deficient information allegations, the trial judge found that for almost all of the relevant time period, few of the pleaded complications or the inadequacies of Ethicon’s clinical evaluations were disclosed in the instructions for use issued with the devices or in any of the promotional material that was tendered in evidence. Substantial amendments to the instructions for use were made in 2015, but the trial judge held that the amended versions still provided inadequate and, in some respects, misleading accounts of the effects of implantation and the risks of the pleaded complications. The promotional material, which included product brochures produced by both Ethicon and JJM, minimised the harm the devices could cause while at the same time exaggerating their benefits.²⁰

In relation to the negligence allegations²¹, the trial judge found that the pre-market evaluations conducted by Ethicon evinced a want of reasonable care for the safety of the women for whose benefit they were intended and promoted. None of the Ethicon devices satisfied the requirements to justify applying a CE mark in order to release them to market. Ethicon’s clinical evaluation reports were manifestly inadequate, and it had no cohesive risk management system and its design control and validation processes were flawed. Ethicon failed to address all known hazards, failed to eliminate or reduce risks as far as possible and it failed to inform users of all residual risks. The court found that a reasonably prudent manufacturer would not have acted in this way.²²

Ethicon’s post-market evaluation of all the devices was also found to be deficient and fall well below the standard of care required of a reasonably prudent manufacturer. Post-market clinical evaluation was haphazard and for years the requirement for preparing clinical evaluation reports was overlooked, if not ignored. The reports that were eventually prepared were wanting in numerous respects. Ethicon’s procedures for risk management and clinical evaluation did not conform to regulatory requirements. Its complaints review system was flawed. It tended to minimise the significance of complaints and to avoid responsibility for adverse events. The information about the potential risks in the instructions for use and promotional material provided by the respondents did not conform to the standard required of a reasonably prudent manufacturer or supplier in their position. In this way, the court found that it fell well short of capturing all known, let alone reasonably foreseeable, risks and was apt to mislead both doctors and patients about the safety and efficacy of the various devices.²³

The Relevance of the Physician/Surgeon Intermediary

The respondents submitted that the extent of safety that a person generally is entitled to expect, necessarily depends, at least in part, on the direct source of the information provided to the ultimate user of the product in question. They pointed out that the Ethicon devices were not supplied directly to the person for whom they were designed but through medical specialists.²⁴
The trial judge held that it may be accepted that treating surgeons would be aware of the risks of pelvic surgery and some pelvic surgeons would have been aware of many, if not most, of the risks associated with the implantation of the various Ethicon devices as a result of their own experience or research. Nevertheless, to the extent that the respondents argued that manufacturers are excused from liability with respect to risks or complications that should be known to doctors or which they are able to discover for themselves, that argument was rejected.²⁵ The Trade Practices Act does not excuse a manufacturer from liability with respect to defects that are unknown to consumers but should or might be known to doctors. To the contrary, consistent with the protective purpose of the legislative scheme, the Act envisages that the manufacturers will fully inform the “learned intermediaries”.²⁶

The fact that the goods in question are supplied through a surgeon does not excuse the manufacturer from its obligation to warn of the risks attendant upon the use of its products, even where those risks might or should be known to the surgeon. It merely affects the way the obligation is discharged.²⁷ The evidence indicated that at least some of the effects on the human body of polypropylene mesh, including the Ethicon devices, were not well-known to the medical or surgical community during the relevant period and that some of the information was not available in the journals commonly read by the cohort.²⁸ In cross-examination, Dr Hinoul conceded that Ethicon had spent hundreds of thousands of dollars on reports, studies and consultancies relating to the foreign body reaction and had access to a body of knowledge on the subject which far surpassed the knowledge of gynaecological surgeons, regardless of their experience.²⁹

Despite views to the contrary expressed by some of the respondents’ witnesses, the trial judge commented that the fact that medical practitioners owe their patients a duty of care does not detract from the existence of a duty of care on the part of the manufacturer or supplier. Indeed, notwithstanding what appeared in their defence, the respondents accepted that they owed a duty to exercise reasonable care to avoid injury to consumers.³⁰

Causation and Hindsight Evidence

The issue of causation was addressed separately in respect of each applicant.³¹ For the purposes of this article it is sufficient to illustrate the issues by reference to the findings for the lead applicant, Mrs Gill.
While there was a dispute about the extent of the injuries Mrs Gill suffered as a result of the implantation of the Prolift Total device, the respondents accepted that the implantation of the device caused some of Mrs Gill’s injuries, including the four episodes of mesh exposure, the consequential surgical procedures, and some of her pelvic pain. Since the use of Prolift Total as intended carried risks of significant and serious injury, including infection, erosion and chronic pain, about which insufficient and misleading warnings were given, and Mrs Gill sustained injury of that kind, she was found to have suffered damage caused by the defect. Having regard to the common position of the parties, that the outcome of the defect case determines the outcome of the application of the Trade Practices Act Pt V, the trial judge held that the respondents’ contraventions of ss 74B and 74D also caused her loss and damage.³²

In relation to negligence, for Mrs Gill, the court was required to apply the factual causation and scope of liability principles in s 5C of the Civil Liability Act 2002 (WA). The respondents argued that the applicants had failed to make out factual causation for the following reasons:

1. That clinical testing is not the only regulatory pathway to market;
2. If clinical tests had been conducted, they would at least have vindicated the sale of the SUI devices because they became “the gold standard” treatment for stress urinary incontinence;
3. The applicants did not call evidence from a regulator to show that registration would have been withheld if the respondents had disclosed certain facts about the testing process for the various devices;
4. The applicants did not put to any of the respondents’ witnesses that they would not have placed the devices on the market had they “known of the asserted problems with the testing regime”; and
5. There was extensive evaluation conducted for all the devices.³³

The trial judge rejected all five of those arguments, noting:

• While it is true that clinical testing is not the only regulatory avenue to market, a manufacturer has to satisfy the essential requirements for CE marking. It may well be the case that the only way to do so in a particular case is through clinical trials. In any case, even if the literature route is followed, the manufacturer is obliged to critically review the literature and “duly” justify reliance on existing clinical data. As with all the other devices, in the case of Prolift, that obligation was not discharged. There was no evidence to indicate, and the respondents did not submit that, without CE marking, Prolift would have been sold in Australia.³⁴
• The fact that the TVT procedure became “the gold standard” treatment for stress urinary incontinence is no answer to the allegation that the negligent evaluation conducted by the respondents of Prolift Total in particular or Prolift in general, either before or after it was cleared for sale, caused damage to Mrs Gill. In the two-year period since July 2020 the device was cleared for sale, the evidence did not support the use of Prolift in the repair of a single compartment, let alone in multiple compartments. A Cochrane review by Maher et al (2007) concluded that the evidence was not sufficient to support the use of any permanent meshes in vaginal repair surgery for prolapse except in the context of randomised controlled clinical trials.³⁵
• The absence of evidence from the regulator is beside the point. It was Ethicon that determined to apply the CE mark.
• The person at Ethicon who made that decision did not give evidence. Nor did any member of Ethicon’s regulatory team. In the circumstances, the trial judge inferred that any evidence any of these people could have given on this question would not have assisted the respondents’ case.
• The proposition that the devices were “extensively evaluated” did not hold good for Prolift in general, let alone Prolift Total, which was the device Mrs Gill received.³⁶

Failure to Warn Claim

In order to succeed in her claim alleging failure to provide adequate warnings and other information, Mrs Gill was required to prove that, but for the respondents’ failure to warn of the pleaded complications and the inadequate evaluations, she would not have consented to implantation with the device. The respondents did not argue that, if factual causation were established, it was inappropriate to extend their liability to the harm caused by their conduct.³⁷

As s 5C(3) of the Civil Liability Act 2002 (WA) prohibits any consideration of the evidence of the injured person, during the trial it was common ground that Mrs Gill’s evidence on this subject must be disregarded. If the common position were correct, then the determination could only be made by drawing inferences from the available evidence including, for example, evidence of her conduct at or about the relevant time; evidence from her about how she felt about certain things; evidence of others in a position to assess her conduct and her apparent feelings or motivations; and other matters which might have influenced her.³⁸ However the trial judge held that the common position was not correct.³⁹

This case, like all cases in the Federal Court of Australia, was heard in the exercise of federal jurisdiction. A state cannot enact a law which governs the exercise by a court of federal jurisdiction.⁴⁰ The effect of s 79(1) of the Judiciary Act 1903 (Cth) is that the restriction on admissibility of the evidence imposed by s 5C(3) of the Civil Liability Act 2002 (WA) applies in this case only if the Constitution or a law of the Commonwealth does not otherwise provide. There is, however, a law of the Commonwealth which otherwise provides, being the Evidence Act 1995 (Cth). It provides for numerous exceptions to the rule that relevant evidence is admissible. None of those exceptions, however, is apt to capture s 5C(3).⁴¹ Mrs Gill’s evidence which had been given for the purposes of her Trade Practices Act claim was therefore admitted for the purposes of her negligence claim.⁴² Mrs Gill was not cross-examined on this evidence.⁴³ However the trial judge recognised the risk of hindsight bias⁴⁴ and scrutinised her evidence accordingly, ultimately finding that, if the respondents had warned of the pleaded complications, then Dr Chapple would have communicated that information to Mrs Gill⁴⁵ and that it was more likely than not that, but for the deficiencies in the information provided by the respondents, Mrs Gill would not have agreed to mesh surgery in general and Prolift in particular.⁴⁶

Damages

The trial judge assessed damages for all three applicants⁴⁷ while leaving some of the arithmetic to the lawyers for the parties, who were given opportunity to read the judgment and to agree upon the orders necessary to give effect to the reasons.

Final orders were foreshadowed to be made on 20 February 2020, assuming agreement between the parties. At the time of writing, final orders had not been published.

Comment

Even before this judgment, in 2017 the Therapeutic Goods Administration⁴⁸ (TGA) cancelled the approval of two types of transvaginal mesh. The first was transvaginal mesh that was inserted through the vagina to treat pelvic organ prolapse. The second was the single incision mini-sling that was used to treat stress urinary incontinence. With the exception of special pathways for accessing unapproved products, such as a clinical trial, these devices can no longer be supplied in Australia. The TGA’s approval for some other types of transvaginal mesh remains in place. Mid-urethral slings for the treatment of stress urinary incontinence can still be supplied in Australia. Transvaginal meshes that are inserted through the abdomen (rather than the vagina) can also be supplied in Australia.⁴⁹

A progress report on implementing the Australian Government Response to the recommendations made in the Senate Community Affairs References Committee inquiry into the “Number of women in Australian who have had transvaginal mesh implants and related matters” was tabled in the Parliament on 2 December 2019.⁵⁰ A detailed review of the progress report is beyond the scope of this article, however it does indicate that most Australian jurisdictions have established services for transvaginal mesh implantation and
removal, and information supports.

Notwithstanding the recent regulatory changes, given the importance of the decision in in Gill v Ethicon Sàrl, it would be surprising not to see an appeal lodged by the three respondents. Time for lodgement of an appeal will not begin to run until final orders are made, so perhaps not before April 2020.

Footnotes

1. Orders made on 21 November 2019.
2. TVT-O, TVT Exact, TVTAbbrevo, and TVT Secur; Gynemesh PS, Prolift, Prolift+M, and Prosima.
3. [3038]. All paragraph number citations below are to Gill v Ethicon Sàrl (No 5) [2019] FCA 1905; BC201910541 unless
otherwise stated.
4. [3052].
5. [3124]–[3131]. The respondents submitted that, as the two Ethicon respondents are incorporated overseas and neither has a place of business in Australia, the statutory causes of action did not apply to them. That submission was rejected. The court also held that their conduct was in trade or commerce, for the purposes of establishing the relevant statutory jurisdiction under the Australian Consumer Law.
6. Referred to in the judgment as SUI devices.
7. Referred to in the judgment as POP devices.
8. [1364]–[1379].
9. The judgment is of such considerable length that this summary does not cover all aspects of it. For example, the limitation period issues are not discussed.
10. [3458], [3500].
11. [3515]–[3517].
12. [2560]–[3035].
13. [1548]–[2444].
14. [1618].
15. [3679].
16. Peterson v Merck Sharpe & Dohme (Aust) Pty Ltd (2010) 266 ALR 1; 184 FCR 1; [2010] FCA 180; BC201001051.
17. [3174].
18. [3165], [3172].
19. [3513].
20. [3260].
21. See the discussion beginning at [3608].
22. [3689].
23. [3672]–[3884].
24. [3210].
25. [3215]–[3216].
26. [3218].
27. [3223].
28. [3228].
29. [3233].
30. [3624].
31. [4427].
32. [4428]–[4429].
33. [4439].
34. See also [4446].
35. [4441]; see C Maher et al, “Surgical management of pelvic organ prolapse in women (Review)” The Cochrane Collaboration (JohnWiley & Sons Ltd, 2007) at 18 (SHI.MESH.00011315
at 1337).
36. [4440]–[4444].
37. [4448].
38. Neal v Ambulance Service of New South Wales [2008] NSWCA
346; BC200810920.
39. [4450]–[4451].
40. [4452].
41. [4456]–[4457].
42. [4459].
43. [4467].
44. [4470].
45. [4492].
46. [4496].
47. [4916]–[5799].
48. Australian Government, Department of Health.
49. www.tga.gov.au/hubs/transvaginal-mesh; viewed on
29 February 2020.
50. www.tga.gov.au/progress-report-australian-government-response-senate-community-affairs-references-committee-report; viewed on 29 February 2020.