Turner v Bayer Australia Ltd (No 3)
[2023] VSC 71
•24 February 2023
| IN THE SUPREME COURT OF VICTORIA | Not Restricted |
AT MELBOURNE
COMMON LAW DIVISION
GROUP PROCEEDINGS LIST
S ECI 2019 02916
| PATRICE SARAH TURNER | Plaintiff |
| v | |
| BAYER AUSTRALIA LTD (ACN 000 138 714) & ORS | Defendants |
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JUDGE: | KEOGH J |
WHERE HELD: | Melbourne |
DATE OF HEARING: | 6 February 2023 |
DATE OF RULING: | 24 February 2023 |
CASE MAY BE CITED AS: | Turner v Bayer Australia Ltd (No 3) |
MEDIUM NEUTRAL CITATION: | [2023] VSC 71 (First revision 6 November 2023) |
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PRACTICE AND PROCEDURE — Pleadings — Further and better particulars — Leave to amend — Supreme Court (General Civil Procedure) Rules2005 (Vic), r 36.04(1).
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APPEARANCES: | Counsel | Solicitors |
| For the Plaintiff | F Forsyth KC with E Levine | Slater & Gordon |
| For the First to Fourth and Sixth Defendants | D Collins KC with D Wong | Clayton Utz |
| For the Fifth Defendant | N Connell (as solicitor) | Mills Oakley |
HIS HONOUR:
This representative proceeding is a product liability action concerning implanted permanent contraceptive medical devices identified collectively as the Essure device. The plaintiff brings the proceeding on behalf of all women who have had an Essure device implanted and suffered harm as a result. She claims damages for breach of the Australian Consumer Law[1] (‘ACL’) and Trade Practices Act 1974 (Cth) (‘TPA’), and in negligence based on allegations of defective design and failure to warn.
[1]Competition and Consumer Act 2010 (Cth), Schedule 2.
The proceeding is listed for trial on an estimate of 12 weeks commencing on 11 April 2023.
In December 2022, the plaintiff filed and served further and better particulars of her amended statement of claim (‘ASOC’).
The first to fourth and sixth defendants (‘Bayer and AMSL defendants’) oppose the plaintiff being granted leave to amend her pleading in accordance with some of the further and better particulars on grounds that the proposal to amend comes at a late stage in the proceeding and without satisfactory explanation, and because the impugned particulars represent an expansion of the plaintiff’s case, and will cause substantial delay and give rise to wasted costs. They submitted that if any of the impugned further particulars were allowed, they should have the opportunity to file and serve further evidence responding to the new allegations.
Statement of claim
Relevant features of the Essure device are pleaded in the ASOC as follows:
14.The Essure Device was comprised of:
a.a micro-insert;
b.a disposable delivery system; and
c.a disposable introducer.
15.The micro-insert in the Essure Device (the Essure Insert):
a.was comprised of:
i)a 316L stainless steel inner coil (the Inner Coil);
ii)a chromium-doped nitinol (nickel-titanium alloy) outer coil (the Outer Coil);
iii)polyethylene terephthalate (PET) fibres;
iv)platinum-iridium bands and bump;
v)silver-tin solder;
b.was a spring-like device;
c.was wound down such that it was approximately 4cm in length and 0.8mm in diameter;
d.expanded up to approximately 2.0 mm in diameter when released;
e.figure 1a (below), obtained from the 2014 Essure Clinical Resource Physician Training Manual, is a depiction (not to scale) of the wound-down Essure Insert;
f.figure 1b (below), obtained from the 2014 Essure Clinical Resource Physician Training Manual, is a depiction (not to scale) of the expanded Essure Insert; and
g.a cross-section of the Outer Coil was rectangular with sharp corners.
16.A woman’s fallopian tubes:
a.have soft tissue walls;
b.are a dynamic environment;
c.vary in size and diameter, depending on the individual; and
d.are peristaltic organs with movement in both directions.
17.The Essure Device was designed to operate as follows:
a.the wound-down Essure Insert was inserted through a woman’s vagina and cervix and placed into her fallopian tube(s) and uterine cavity using the disposable delivery system and/or disposable introducer;
b.figure 1c (below), obtained from the 2014 Essure Clinical Resource Physician Training Manual, is a depiction (not to scale) of the intended placement of the Essure Insert in a fallopian tube and uterine cavity;
c.the Essure Insert was released from the disposable delivery system and/or disposable introducer and the Outer Coil expanded;
d.on expansion, the edges of the Outer Coil disrupted the soft tissue in the walls of the fallopian tube and the Essure Insert anchored in the fallopian tube;
e.the initial presence of the Essure Insert triggered an acute inflammatory response;
f.the continued presence of the Essure Insert triggered a foreign body and/or chronic inflammatory response;
g.the acute and chronic inflammatory responses and/or foreign body responses resulted in, among other things, tissue in-growth into the coils of the Essure Insert and around the PET fibres;
h.the tissue in-growth around the Essure Insert caused occlusion of the fallopian tube(s);
i.occlusion of the fallopian tube(s) prevented pregnancy; and
j.the Essure Insert operated as an intrauterine device.
In Part D of the ASOC, the plaintiff set out allegations as to defects of the Essure device:
18At all material times, by reason of one or more of the matters alleged in paragraphs 14 to 17, the Essure Insert:
a.disrupted the inner layers of the uterine horn and/or the fallopian tubes;
b.caused initial acute inflammation in the fallopian tubes and/or endometrium;
c.caused ongoing chronic inflammation in the fallopian tubes and/or endometrium; and/or
d.incited a foreign body response to the Essure Insert in the fallopian tubes and/or endometrium and/or uterine cavity
(the Inherent Defects).
19At all material times, by reason of one or more of the matters alleged in paragraphs 14 to 17 there was a risk that, following implantation, the Essure Insert:
a.would:
i.migrate, including into the abdominal cavity;
ii.be expulsed from the fallopian tube and/or uterus;
iii.break or fragment;
iv.corrode;
v.fatigue; and/or
b.would perforate the fallopian tube, uterus or other organs such as the bowel; and/or
c.would:
i.leach nickel or other metals into the body of the recipient; and/or
ii.exacerbate pelvic pain or menstrual bleeding conditions.
(the Failure Defects).
The plaintiff pleads that women who had the Essure device implanted faced certain risks by reason of the alleged defects:
20At all material times, by reason of one or more of the Inherent Defects and/or of the Failure Defects, there was a risk that the Essure Insert would cause:
a.pain or increased pain, including serious, chronic and/or recurring pain;
b.new, increased or worsened menorrhagia (heavy menstrual bleeding);
c.new, increased or worsened dysmenorrhoea (intense uterine cramping and pain); and/or
d.damage to internal organs.
(the Adverse Events).
The plaintiff pleads that a woman who experienced adverse events would be unable to resolve them through removal of the device without abdominal surgery:
21.Once anchored into the fallopian tube(s), the Essure Insert:
a.was not designed to be removed;
b.was unlikely to be able to [be] removed without surgery; and
c.could likely only be removed by:
i)a salpingectomy (removal of fallopian tubes); or
ii)a hysterectomy (removal of uterus).
22.By reason of the matters alleged in the preceding paragraph, in the event that a woman experienced Adverse Events or other complications associated with the Essure Insert, she would be unable to resolve the Adverse Events or other complications through removal of the Essure Insert without abdominal surgery and likely the removal of one or more organs (the Removal Limitation).
The plaintiff alleges in paragraph 23 of the ASOC that she and group members suffered injuries as a result of implantation of the Essure device by reason of one or more of the inherent defects, the failure defects and/or the removal limitation and/or the occurrence of one or more of the adverse events.
The plaintiff pleads the defendants were responsible for publishing marketing material relating to the Essure device directed to potential recipients that did not adequately disclose the existence of the inherent defects, the failure defects, the risk of adverse events and/or the removal limitation.
The ASOC pleads causes of action for statutory breaches of the ACL and TPA, and in negligence. Relevant to those causes of action the plaintiff set out in the ASOC what she alleges to be the foreseeability, or the defendants’ actual or constructive knowledge of the risk of harm to women who had the Essure device implanted as a result of the inherent defects, the failure defects, risk of adverse events and/or the removal limitation. The negligence claim includes an alleged failure to warn potential recipients of that risk, or to notify women who had the device implanted after further information about risk became available.
Procedural history
The writ commencing the proceeding was filed by the plaintiff on 28 June 2019.
The plaintiff filed a statement of claim on 20 December 2019. The plaintiff filed an ASOC on 23 December 2022. The amendments to the plaintiff’s pleading are not material to these reasons.
Defences were filed in September 2020.
Case management of the proceeding effectively began in 2021. Orders for discovery were made in March of that year. Very substantial discovery was made by the Bayer and AMSL defendants in 2021 and 2022 in accordance with those and subsequent orders.
In 2021 the process of identifying fields of expertise relevant to the plaintiff’s claim began. In that context, in March 2021, the Bayer and AMSL defendants complained that the ASOC contained broad and unspecific allegations, did not plead the causal links between the alleged defects in the Essure device and the injuries suffered by group members, and thus lacked necessary detail about key allegations to enable the defendants to understand the case they had to meet. The defendants complained that this made it difficult for them to identify with any specificity the subject matter areas in which they would require expert evidence. In correspondence to the plaintiff’s solicitors of 26 March 2021, the Bayer and AMSL defendants said:
7.Related to these issues is the fact that as it presently stands, the Statement of Claim lacks necessary detail about key allegations made against the Defendants. The subject matter areas of expert evidence required to be called in this proceeding will likely vary depending on the causal links that are alleged to exist between the alleged “defects” on the one hand, and the injuries, loss or damage claimed to have been suffered by the Plaintiff and group members on the other hand. At present, those causal links are insufficiently particularised to enable the Defendants to sensibly identify the required areas of expert evidence, or the questions to be addressed by the experts.
8.To this end, fundamentally, the Statement of Claim does not connect, with sufficient detail:
(a)the aspects of the design of the Essure Device (as pleaded in paragraphs 14 to 17 collectively) on the one hand, with either (i) the “Inherent Defects” or (ii) the “Failure Defects” (as pleaded in paragraphs 18 and 19, respectively);
(b)the “Adverse Events” (as pleaded in paragraph 20) with either (i) the “Inherent Defects” or (ii) the “Failure Defects” (as pleaded in paragraphs 18 and 19, respectively); or
(c)the “Essure Insert Defects” (as pleaded in paragraphs 18 to 22 collectively) on the one hand, with either (i) the “injuries” alleged in paragraph 23, or (ii) the loss or damage alleged in paragraphs 60, 72-75, 86-88, 96-97, 105,106 and 114-115, on the other hand.
The Bayer and AMSL defendants sought further particulars of the plaintiff’s ASOC and greater precision as to the disciplines from which the plaintiff proposed to call expert evidence, and the way in which those disciplines related to the pleaded case in order to assist in the expert evidence process.
The plaintiff responded in correspondence of 7 April 2021 that read in part:
1.Your request for further particulars in paragraph 14 of your letter is not a proper request for particulars. The Statement of Claim properly identifies the design elements relied on and the combined effect of one or more of them to allege defects in the Essure Device. The manner in which each of the design elements is alleged to have given rise to the various identified defects and to injuries, loss and damage is an area properly for expert evidence. Until discovery is obtained and such evidence is sought, the Plaintiff cannot provide any further particularity.
2.Nevertheless, the Plaintiff can, at this stage give the following further information in response to your request. Such a response will likely require further refinement following the filing of expert evidence.
The plaintiff responded to the request for further particulars in relatively general terms, and added:
each of the Inherent Defects and Failure Defects (individually or together) are alleged to have given rise to a risk that the Essure insert would cause Adverse Events 20(a) to (c);
The Bayer and AMSL defendants responded in April 2021 acknowledging that the plaintiff was not then able to provide greater particularity as to her case, and suggested:
6.Given the Plaintiff’s inability to provide satisfactory particulars of her allegations of defect, we suggest an alternative way forward to enable areas of expertise to be identified. While the “manner in which each of the design elements is alleged to have given rise to the various defects and to injuries, loss and damage” may be a matter for expert evidence, that should not prevent the Plaintiffs from identifying the expert evidence she believes will be required in respect of each of the presently pleaded allegations.
7.If the Defendants can understand the connection between the Plaintiff’s proposed areas of expert evidence and the key allegations made against them, then they will be better able to formulate proposed areas of expert evidence in response.
At a case management conference (‘CMC’) on 29 April 2021 the plaintiff reinforced she would require expert evidence in order to clearly articulate the path for each particular claim, and to identify the way in which the expert disciplines were alleged to relate to her pleaded case.
On 30 June 2021, in compliance with an order requiring identification of expert evidence areas, the plaintiff said in relation to biomedical engineering:
This evidence will consider the structure of the device with particular focus on the mechanical aspects of the design along with its metallic and other composition.
And in relation to immunology:
This evidence will opine on the alleged inflammatory and foreign body response (SOC para 18) including by reason of the structure and design of the device (SOC paras 15 and 17) and the potential for leaching metals (SOC 19(c)(i)). This evidence will consider the likely symptoms from the body’s immunological response (SOC para 20).
On 9 July 2021, the Bayer and AMSL defendants sought further clarification from the plaintiff, including as to ‘other metals’ pleaded in paragraph 19(c)(i). The plaintiff responded by saying ‘other metals’ referred to chromium. The plaintiff said that in part her case related to the immunological response to the leaching of nickel and other metals into the body, and added:
The Plaintiff does not allege that an “immunological response” is the only mechanism by which the pleaded Defects cause the Adverse Events. For example, the risk of corrosion is alleged to lead to breakage and perforation of an organ which is not an immunological response. However, immunology includes the physical, chemical and biological reactions of the body against foreign substances.
On 21 July 2021, the Bayer and AMSL defendants responded noting that there remained uncertainty and imprecision about the expert disciplines, and how the evidence of experts would relate to the allegations in the ASOC.
The parties continued to correspond about expert evidence and how it related to the plaintiff’s pleaded claim until a CMC held on 5 August 2021. At that CMC the plaintiff proposed an order that all parties file and serve their primary expert reports by the same date. The Bayer and AMSL defendants argued that because the process of correspondence and discussion between the parties had not revealed the connection between the alleged inherent defects, failure defects, adverse events and injury, it would only be after receipt of the plaintiff’s expert reports that the defendants would be able to ascertain the case they needed to meet. Counsel for the defendants said: ‘Because once we get their reports, the case will speak for itself.’
Addressing the issue of the immunology and biomedical engineering disciplines, counsel for the defendants said:
Using examples, for example, whether a foreign body response is said to be a response to nickel leaching from the device or chromium leaching from the device, the rate of leaching. It may be a different type of foreign body response. It might be some sort of allergic response to either those materials or other materials. It might be some autoimmune response.
The defendants submitted the plaintiff should be required to file and serve her expert reports first, with the defendants having a number of months then to file and serve their expert reports.
I largely accepted the defendants’ submissions and on 28 September 2021 made the following orders in relation to expert evidence:
12.By 12 November 2021, the parties serve on each other party to the proceeding a proposed:
a.List of experts from whom it intends to adduce evidence at trial;
b.Document setting out the question or questions each expert will be asked to opine on;
c.A list of all documents made available to the expert pursuant to their engagement in this proceeding, including any letters of instruction.
13.By 1 December 2021, the parties serve on each other party the settled version of documents provided under order 12.
14.Each party shall, within seven (7) days after delivering to any expert any instructions or making available to an expert any further documents, serve upon each other party a list of those further documents, copy of the further instructions and copy of the further documents (save that if a document has previously been produced to the parties in this proceeding it need not be reproduced).
15.By 18 March 2022, the plaintiff is to file and serve the expert report of each expert she intends to call at trial.
16.By 6 May 2022, the defendants file and serve the expert reports of each expert they intend to call at trial.
17.By 27 May 2022, the plaintiff file any expert reports in reply.
18.By 10 June 2022, the parties are to confer about expert conclaves.
The parties experienced some delay in obtaining and exchanging expert reports. Most of the plaintiff’s primary reports were filed and served in early May 2022. The defendants’ reports were filed and served in late July and early August of 2022. The plaintiff’s reply reports were filed and served in October of that year.
Particulars
There were over 20 instances where the plaintiff’s ASOC pleaded that further particulars may be provided following discovery and the filing of expert evidence.
In the second half of 2022, the Bayer and AMSL defendants agitated for provision of those particulars by the plaintiff.
The plaintiff served lengthy further and better particulars of her ASOC on 16 December 2022. The particulars appear to be based on the plaintiff’s expert evidence and on documents relevant to the proceeding, many of which have been discovered by the Bayer and AMSL defendants.
The function of particulars is set out in r 13.10 of the Supreme Court (General Civil Procedure) Rules 2015 (Vic) (‘Rules’):
(1)Every pleading shall contain the necessary particulars of any fact or matter pleaded.
(2)Without limiting paragraph (1), particulars shall be given if they are necessary—
(a) to enable the opposite party to plead;
(b)to define the questions for trial; or
(c)to avoid surprise at trial.
In Wheelahan v City of Casey (No 12),[2] Dixon J described the function of particulars as follows:
particulars are not intended to fill gaps in a deficient pleading. Rather, they are intended to meet a separate requirement – namely, to fill in the picture of the plaintiff’s cause of action (or defendant’s defence) with information sufficiently detailed to put the other party on guard as to the case that must be met. An object and function of particulars is to limit the generality of a pleading and thereby limit and define the issues to be tried;
[2][2013] VSC 316, [25(k)] (citations omitted).
Particulars are part of the pleading, and are subject to the Rules in relation to amendment.[3] In Northern Health v Kuipers,[4] the Court of Appeal said in relation to case management principles and amendment of pleadings:
[3]Supreme Court (General Civil Procedure) Rules 2015 (Vic), rr 1.13 and 36.04(1).
[4][2015] VSCA 172 (Kyrou JA, McLeish JA) (citations omitted).
28.The principles pertaining to an application to amend a pleading were explained in Aon Risk Services Australia Ltd v Australian National University. As set out in the reasons of J Forrest J in Ultra Thoroughbred Racing Pty Ltd v Those Certain Underwriters at Lloyd’s, London, the factors that the High Court in Aon considered as relevant to an application to amend a pleading include:
(a)whether there will be a substantial delay caused by the amendment;
(b)the extent of any wasted costs;
(c)whether there is an irreparable element of unfair prejudice caused by the amendment;
(d)concerns of case management arising from the stage in the proceeding when the amendment is sought;
(e)whether the grant of the amendment will lessen public confidence in the judicial system; and
(f)whether a satisfactory explanation has been given for seeking the amendment at the stage when it is sought.
33.It has been said by this Court that Aon may have ‘re-invigorated the procedural paradigm’ insofar as time, costs and limited judicial resources are relevant considerations in the determination of whether to allow certain interlocutory processes. However, as J Forrest J observed in Ultra, ‘the primary question still remains: what do the interests of justice dictate?’; Aon reminds courts that ‘the prism through which these interests are viewed is wider than just that of the moving party’.
A pleading is to be understood in its context.[5] In this case, that context obviously and importantly includes the expert evidence filed and served by the plaintiff.
[5]Baird v Queensland (2006) 156 FCR 451, 455 [17] (Allsop J); Wotton v State of Queensland (No 5) (2016) 352 ALR 146, 170 [62] (Mortimer J).
The plaintiff submitted that it was always contemplated since she filed the statement of claim that further particulars would be provided following discovery and filing of expert evidence. She submitted the particulars provided were comprehensive and extended to the identification of evidence in expert reports and discovered documents. She noted the Bayer and AMSL defendants had provided particulars of the defence on topics not previously pleaded simply by referring to paragraphs of lay and expert evidence. The plaintiff submitted the particulars did not have the effect of amending or expanding her case, and in any event there was no prejudice flowing to the Bayer and AMSL defendants, particularly because most of the particulars that were subject to complaint arose from expert reports that were filed and served in May 2022.
The Bayer and AMSL defendants submitted that the impugned particulars came at a late stage in the proceeding without satisfactory explanation from the plaintiff, would cause substantial delay and give rise to wasted costs. Relying on an affidavit of Gregory Williams sworn 25 January 2023, the defendants submitted that many of the proposed particulars to which they object represent the first time that the plaintiff has sought to put her case on a particular basis, and would likely have been the subject of different lay and/or expert evidence had those allegations previously formed part of the plaintiff’s pleaded case. In relation to paragraphs 18 to 22 of the ASOC, reproduced at paragraphs 6 to 8 above, the defendants submitted:
(a)The plaintiff, by her pleading (in the form it has assumed since it was filed in December 2019), specifically pleads that the Inherent Defects and the Failure Defects as conceptually distinct matters. While both the Inherent Defects and the Failure Defects are alleged to cause the pleaded Adverse Events, there is no allegation that any aspects of an Inherent Defect or Failure Defect cause, or are in any way linked to, each other. Further, the material facts alleged to give rise to the Inherent Defects and the Failure Defects are expressly limited to the specific features of the ‘design’ of the Essure Device that are pleaded at ASOC [14]-[17]. A number of the proposed amendments, however, seek to resile from this position.
(b)The plaintiff ought not be permitted to resile from this position at this late stage. At all relevant times, the Bayer and AMSL Defendants were entitled (and indeed, were required) to prepare their case on the basis of the matters formally pleaded by the plaintiff in the Statement of Claim. In preparing for trial, they were not required to respond to allegations (or marshal evidence) that fell outside of the case as advanced in the plaintiff’s pleading. Indeed, had they done so, that material, properly construed, would not have been relevant to the matters in issue in the proceeding {Evidence Act 2008 (Vic) s 55}.
Paragraphs 18, 19 and 20
The plaintiff provided extensive further and better particulars to paragraphs 18, 19 and 20 of the ASOC. The Bayer and AMSL defendants object to the following particulars:
As to paragraph 18(b), the acute inflammatory response to the Essure Insert occurred by reason of:
(i)the presence of non-degradable, synthetic material;
(iv)localised release of toxic metal ions.
As to paragraph 18(c), an ongoing chronic inflammatory response to the Essure Insert occurred by reason of:
(iv)the metal and synthetic components of the Essure Insert including the mixing of metals of different electrochemical potential;
(v)corrosion and metal ion release;
As to the risk of corrosion, fatigue and leaching metals pleaded in paragraph 19:
(i)the constituent materials in the Essure Insert (stainless steel (SS), NiTi, Pt, Tin), and the mixing of metals, caused a risk of corrosion and accelerated dissolution of metals, leaching metal ions into the surrounding environment;
As to the risk of breakage or fragmentation pleaded in paragraph 19:
(ii)corrosion and leaching metals increases the risk of breakage and fragmentation.
As to paragraphs 20(a) and 20(c):
(i)pelvic pain is initially due to tubal spasm, and later due to a foreign body reaction or local or systemic reaction to Essure Insert’s nickel or polyethylene terephthalate fibres (PET) and/or chronic inflammation;
(iv)migration of the Essure Insert and the resulting adhesions and tissue injury in the peritoneal cavity trigger new wound healing responses and chronic inflammation, which effects are associated with elevated pain sensitisation which compounds and aggravates chronic pelvic pain;
(v)ongoing chronic inflammation increase the intensity of pain, and increases the duration or proportion of time in which the sensation of pain is triggered; and/or
(vi)the risk of chronic pelvic pain is higher when migration, corrosion, or breakage of the Essure Insert causes a greater degree of fallopian tube and uterine inflammation, or more disseminated chronic inflammation in the pelvic cavity.[6]
[6]Emphasis added.
It is necessary to consider briefly some of the expert evidence.
The plaintiff relies on Professor Chrzanowski, who has experience in nanomedicine, biomedical engineering and biomaterials. In his report dated 6 May 2022, Professor Chrzanowski commented on the design of the Essure device:
The analysis of the Essure device in the context of its design and used materials (including surface finish) showed that the Essure device was constructed to intentionally maximise the foreign body response and to promote chronic inflammatory responses.
Professor Chrzanowski identified what he said were a number of real risks associated with use of the Essure device that included:
corrosion of the metal components of the Essure device that leads to the leaching of toxic metal ions into tissues surrounding the Essure device (localised toxicity)
Professor Chrzanowski continued:
Based on my expertise the consequence of the impanation of the Essure device can be: chronic inflammation, the fibrosis and stiffening of the wall of the fallopian tube, occasional bleeding due to microinjuries, necrosis (cell death) around the device, and localised allergic reactions and toxicity due to release of metal ions, as well as infections. While clinical outcomes are outside my core competencies, I anticipate that these clinical consequences could present as pain (including neuropathic pain), inflammation (that is not confined to the areas adjacent to the device), irritation, and discomfort perceived in the areas around the device, as it was evidenced in (BAY-JCCP-1120653).
Commenting on what he said were the foreign body and inflammatory responses triggered by the Essure device, Professor Chrzanowski said:
This reaction is triggered by the presence of nondegradable, synthetic materials – metals and polymer – which cumulatively promote inflammatory responses. The inflammatory response is also triggered by the direct contact of the metal coil with soft tissues, which interferes with natural lining of the fallopian tube and physically impinges into the tissue (Fig. 1, 4). In addition, the metal components of the Essure device corrode in bodily environment, which results in a localised release of toxic metal ions, i.e., Ni, Cr (please see #2.2.; Fig. 4; BAY294 EDPA-1737787 → BAY-EDPA-7337805). These metal ions induce oxidative stress and toxicity, thus trigger the immune response.
Professor Chrzanowski said risks following insertion of the device included ‘[d]egradation of the device – corrosion’. He gave the following example of materialisation of a risk associated with the device:
For example, a fracture of the Essure device ⑤ 390 can lead to a further dislocation of the device ④ and a likely consequence of both is a mechanical injury that leads to Ⓑ inflammatory response and scar formation.
Professor Chrzanowski said some of the risks he identified were interdependent and could cause cumulative or synergistic effects.
Commenting on the metals used in the device Professor Chrzanowski said:
Nitinol and stainless steel are known to trigger the foreign body response, unless their surfaces are specifically modified to reduce the corrosion and increase the functional integration with the host tissues. Both metal alloys release a small amount of metal ions (Cr, Ni, Fe, Ti) due to the corrosion, which occurs in corrosive environment of human body and was confirmed in the corrosion susceptibility test (BAY-EDPA-1737787 → BAY-EDPA560 7337805). The consequence of locally release metal ions is the upregulation of immune response, oxidative stress, and localised cell death (necrosis).
Contrasting ingestion of metals to release from an implantable device, Professor Chrzanowski said:
In contrast the metal ions released from an implantable device is directly delivered to cells and tissues that surround the device. Their local and cumulative concertation is higher; thus, they cause a real risk of local toxicity.
And dealing with the relationship between release of metal ions and the inflammatory response, he said:
In my opinion, on the balance of probability, it is likely that Ni, Cr, Fe and Ti ions are release from the Essure device and contribute to the chronic inflammatory response. Unless the surface of the Essure device can be oxidised (self-passivated), which would reduce the corrosion processes, we will observe a continuous release of the metal ions into the body environment. Consequently, the prolonged ion release leads to the chronic inflammatory response.
The plaintiff also relies on Professor Robertson, a professor of reproductive immunology with knowledge in reproductive biology, biomedicine, immunology, endocrinology and the immune consequences and causes of injury of the female reproductive tract. Commenting in summary on the risk of adverse effects from implantation of the Essure device, Professor Robertson said:
In my opinion, in broad terms, the ability to cause adverse effects is due to the combination of the intended site of placement of the Essure Device in the female reproductive tract and the physical features of the Device itself. The uterus and fallopian tube have an unusual hyper-vigilant immune response and propensity to inflammation, and unique physical features that impair normal wound healing responses and facilitate device migration. The Device itself is intended to cause short-term cellular injury and inflammation, is prone to corrode and sometimes break, and leaches metals known to exert toxic and pro-inflammatory effects.
Commenting on the materials contained in the Essure device, Professor Robertson said:
108.In my opinion, the Essure Device contains materials that have potential to interact with immune cells in the site of the Device. This effect is in addition to eliciting a Foreign Body Response in some women (for details see paras 435-452). This will be particularly problematic in women with a persistent chronic inflammatory response. The metals may be leached by the Device, particularly in the event of Device corrosion. The PET core of the Device also has potential to interact with immune cells. Both materials are causally implicated in the risks of the Device and its attributed risks of adverse impact in recipients.
109.The outer nitinol coil of the Device contains toxic metals nickel and chromium, which are implicated in the elevated risk of adverse health effects in recipients of medical devices more broadly. There is also evidence that iron present in the stainless steel, and tin present in the weld components of the device, have adverse health effects (for details, see paras. 663-667).
110.There is evidence that particles of these metals affect the immune and inflammatory response in ways that promote inflammation. It is well-known from many studies that wound healing processes can be complicated by metal particles leached from medical devices made of these metals. Indeed, eliciting a chronic wound accompanied by chronic inflammation is an unintended consequences common to metal devices. In the event that corrosion occurs, nickel and chromium promote a pro-inflammatory M1 phenotype (as opposed to anti-inflammatory M2 phenotype) in macrophages, to further interfere with wound healing (for details, see paras. 660-662). If corrosion occurs and metal particles are leached, I expect this to increase the likelihood of persistent inflammation in the Device site, and compound the effects on uterine tissues of inflammation and innate immune memory described above (see paras 85-89).
The Bayer and AMSL defendants rely on Dr Eiselstein, a materials and corrosion engineer, Professor Badylak, who has qualifications and experience in pathology, biomaterials, tissue engineering and regenerative medicine, and assistant professor and physician Dr Sokol, who has training and experience in allergy and immunology.
Dr Eiselstein was asked to define terms in relation to a metal component of an implantable device including ‘corrode’ and ‘leach’, and to describe the process that may lead to metal ions leaching or otherwise being released from an implantable device. He was specifically asked to comment on Professor Chrzanowski’s opinion relating to:
asserted “failure of stainless-steel devices has been reported to be associated primarily with corrosion (toxicity, insufficient biocompatibility) and deformation / fractures” …
Dr Eiselstein was asked to provide any other comments he considered appropriate on the opinions expressed in Professor Chrzanowski’s report. Responding to this request, Dr Eiselstein considered issues of corrosion, toxicity and release of metal ions.
In relation to Professor Robertson’s report, Dr Eiselstein was asked to comment on:
e.the statement that the Essure Device “leaches metals known to exert toxic and pro-inflammatory effects” referred to in paragraph 8, the assertion of corrosion of the Essure Device in situ ”which increases leaching of noxious metals from the Device” referred to in paragraph 103 and the more detailed explanation of this opinion which appears at paragraphs 639 to 645. In particular, please comment on Professor Robertson’s statement that “the Essure Device was not tested for its biocompatibility with the fallopian tube or uterine fluids or tissues, and formal studies to evaluate effects of Device corrosion were not performed” at paragraph 643;
f.the assertion of metal leaching referred to in paragraphs 108 to 117;
Dr Eiselstein considered aspects of Professor Robertson’s opinion dealing with the potential of the Essure device to cause a chronic inflammatory response by leaching of metal ions and particles and by reason of its polyethylene terephthalate (‘PET’) core. Dr Eiselstein considered in detail aspects of Professor Robertson’s opinion dealing with corrosion, leaching or release of metal ions, the response to PET fibres, and the potential to exert toxic or pro-inflammatory effects.
In his report, Dr Badylak described what is meant by the terms ‘biomaterial’ and ‘biocompatibility’. He set out 15 different tests used to determine biocompatibility, a number of which addressed issues of toxicity. In the context of biomaterials, Dr Badylak explained certain terms including ‘corrode’ and ‘leach’. Dr Badylak was invited to comment generally on the reports of Professors Chrzanowski and Robertson. He was specifically asked to comment on Professor Robertson’s report that the Essure device was prone to corrode and leach metals known to exert toxic and pro-inflammatory effects. Further, Dr Badylak was asked to comment on Professor Robertson’s opinion about the foreign body responses initiated by the PET core of the Essure device.
A biomaterials conclave involving Professors Chrzanowski and Robertson and Doctors Eiselstein and Badylak was held in January this year. In the joint report prepared following the conclave, the experts considered in great detail each component and constituent material of the Essure device in the context of the body’s response to the device, including under the headings foreign body response, acute and chronic inflammation, chronic wound response, corrosion including galvanic corrosion, local toxicity, leaching, hypersensitivity reaction and metal release. In the report, Dr Eiselstein directly responded to opinions expressed by Professors Robertson and Chrzanowski about the toxicity of metal constituents of the Essure device and related matters including the potential for corrosion. The experts gave detailed consideration to what is meant by each of those terms. In the report the experts considered and expressed opinions about risks that may be associated with the Essure device. These included the risks of corrosion, breaking or fragmenting, migration and expulsion. The experts addressed consequences of each of those risks.
Particular (i) to paragraphs 20(a) and (c) is taken directly from the primary report of Professor Korda, the gynaecologist engaged by the plaintiff. Professor Korda’s report filed 6 May 2022 included the following:
In my opinion pelvic pain is initially due to tubal spasm, and later due to a foreign body reaction or local or systemic reaction to nickel or polyethylene terephthalate fibres and or chronic inflammation.
Migration is pleaded as a failure defect in paragraph 19. Extensive consideration of the issue of migration in Professor Robertson’s first report included:
105.Migration from the fallopian tube into the peritoneal cavity substantially increase the risk of injury and impaired function to tissues elsewhere in the peritoneal cavity, such as the bowel and the ovary. Device migration would have a high likelihood of causing adhesions between organs and tissues in the peritoneal cavity. In turn, adhesions and tissue injury in the peritoneal cavity would trigger new wound healing responses, with potential for further chronic wound responses and chronic inflammation to arise. These effects would be associated with elevated pain sensitisation and perception and would likely further compound and aggravate chronic pelvic pain (for details, see para. 596).
550.Migration of the Essure Device is likely to cause further tissue disruption and de novo problems at the unintended site of location. A migrating Device has potential to cause perforation of the fallopian tube or uterine wall into the abdominal cavity, or movement via the infundibulum of the fallopian tube into the peritoneal cavity, or expulsion through the cervix and/or out of the vagina. If the Essure Device migrates to the peritoneal cavity it will likely cause damage to other organs in the cavity, such as the bowel, bladder, ovaries, or other parts of the female reproductive tract.
The Bayer and AMSL defendants specifically asked gynaecological pathologist Dr Murdoch to comment on the design features and components of the Essure device, and the physiological risks identified by Professor Robertson, including as to migration.
I have only included in this ruling a few brief references from the very lengthy expert reports that appear to comprehensively consider the Essure device, its constituent elements, the body’s reaction to it, and the potential risks for women who have the device implanted. There are similarly comprehensive individual and joint reports in other disciplines, including gynaecology and immunology.
I reject the defendants’ submission that reference to ‘synthetic material’ and ‘toxic metal ions’ in particulars to paragraph 18(b), or the references to metal and synthetic components, corrosion and metal ion release in particulars to paragraph 18(c) represent new or unexpected allegations by the plaintiff to which the defendants have not had the opportunity to respond. The composition of the Essure device, including metals and PET fibres, has always been pleaded as a cause of an inflammatory response to implantation. The further and better particulars set out the mechanism or means by which the inflammatory response is induced, thus limiting the generality of the pleaded allegations. The biomaterials experts have considered the relevance of the role of synthetic PET fibres, metal ions that might be released by the device, corrosion including galvanic corrosion and toxicity to the inflammatory response allegedly caused by the Essure device when implanted. The defendants’ experts have responded to the opinions about these matters expressed by Professors Chrzanowski and Robertson in their primary reports. There has also been further consideration of these issues in the joint biomaterials report.
The same observations apply to the references to mixing of metals, leaching metal ions and corrosion and leaching metals that appear in the particulars to paragraph 19 of the ASOC.
Paragraphs 20(c)–(d) plead that the inherent defects and/or failure defects gave rise to a risk of pain and damage to internal organs. Allegations that expulsion of an Essure device from the fallopian tube and uterus, and migration of the device into the abdominal cavity, may result in adhesions, new wound healing responses and chronic inflammation, are consistent with other matters pleaded in paragraphs 18, 19 and 20, and with expert evidence relied on by the plaintiff. Further, the allegations are not surprising.
The plaintiff’s further and better particulars to paragraph 20 of the ASOC, including those sought to be impugned by the Bayer and AMSL defendants, have the effect of limiting the generality of what were quite broad allegations. Further, as I have already observed, the particulars closely follow opinions expressed by Professors Korda and Robertson in their primary reports, and are not surprising in the context of the allegations pleaded in the ASOC.
I also reject the Bayer and AMSL defendants’ broader complaint about the manner in which the plaintiff has pleaded and particularised Part D of the statement ASOC of claim which includes the inherent defects, failure defects and adverse events. In summary, the ASOC pleads the relevant design features of the Essure device (paragraphs 14–17), the way in which the device was designed to operate (paragraph 18), the way in which the device might fail (paragraph 19), the consequent risk of harm to recipients of the device (paragraphs 18–22), and the injuries that were thereby caused (paragraph 23). In relation to risk of harm and causation, the pleading does not draw a clear line between the inherent defects and the failure defects. The plaintiff pleaded the risk of adverse events arose by reason of one or more of the inherent defects and/or the failure defects, and that injuries were caused by reason of one or more of the inherent defects, the failure defects and/or the removal limitation and/or the occurrence of one or more of the adverse events. Expert evidence was always going to be necessary to limit the generality of the pleading by explaining how implantation of the device might give rise to certain risks and cause certain injuries. The expert evidence appears to be an attempt to explain a complex physiological reaction to implantation of the device given allegations as to the manner in which it was designed to operate, how it might fail, and the risk of adverse events that might ensue. The plaintiff has now particularised her case in line with the expert evidence. There is nothing objectionable about the form of paragraphs 14 to 22 of the ASOC, or the particulars based on expert evidence that have now been provided.
The Bayer and AMSL defendants were aware at all times that the plaintiff would rely on expert evidence to particularise her case. The plaintiff’s expert reports were served in May 2022. The defendants took the opportunity to have their experts respond to the plaintiff’s expert evidence. There was a further opportunity for experts to respond to issues during the conclave process and in the joint reports that have been prepared. In the circumstances there is no unfair prejudice to the defendants from the delivery of particulars in December 2022.
There is one caveat to what I have said. In his primary report, Professor Chrzanowski set out the metals and metal ions relevant to the physiological response to implantation of the Essure device, which I understand to include chromium, nickel, iron, titanium and tin. However, in correspondence in 2021, the plaintiff’s solicitors limited relevant metals to nickel and chromium. Although it is not apparent that the defendants’ experts limited their consideration of metals to nickel and chromium, I concluded it was appropriate that the plaintiff be required to specify precisely the metals and metal ions relied on, and to give the Bayer and AMSL defendants an opportunity to ask their experts further questions about metals, other than nickel and chromium, now relied on by the plaintiff.
Paragraphs 23 and 67(b)
Paragraph 23 of the ASOC sets out the pleaded injuries. Paragraph 67 pleads the standard of care, and relies on the particulars to paragraph 23 in support of an allegation that the risk of harm resulting from implantation of the device was not insignificant.
Particulars of injuries to group members now pleaded in paragraph 23 of the ASOC include:
(vii)By reason of the Failure Defects, in some Group Members the Essure Device migrated, was expulsed from the fallopian tube or uterus, broke or fragmented, corroded, fatigued and/or leached nickel or other metals into the body of the recipient.
(viii)By reason of the matters in the previous sub-paragraph, some Group Members suffered:
A.disruption of tissue;
B.acute inflammation;
C.chronic or persistent chronic inflammation; and/or
…
E.… resulting sexual dysfunction, …;
F.in some cases requiring:
1.hysterectomy (with or without bilateral or unilateral salpingectomy and with or without oophorectomy);
2.salpingectomy (bilateral or unilateral, with or without oophorectomy and/or corneal resection);
3.surgery to investigate the cause of symptoms or conditions;
4.other surgery to excise the device from the body; and/or
5.removal of other organs or part of an organ.[7]
[7]Emphasis added.
The alleged risk that an Essure device would be expulsed from the fallopian tube, migrate into the abdominal cavity, and risk increased pain and damage to internal organs has always been part of the plaintiff’s pleaded case. Allegations of disruption of tissue, inflammation beyond the fallopian tubes and endometrium, and the possible need for surgery involving removal of organs are within the generality of the paragraph 20 pleading of adverse events. Professors Robertson and Korda both discussed the effect of chronic pelvic pain on sexual function in their primary reports, and the particulars are consistent with the opinions they expressed. Further, as I have already observed the allegations are unsurprising.
The particulars to paragraph 23 are unobjectionable.
Paragraph 25
In paragraph 24 of the ASOC the plaintiff particularised patient information booklets and brochures relating to the Essure device, directed to potential recipients of the device that she alleges were published by the defendants in Australia (‘marketing material’).
In paragraph 25 of the ASOC the plaintiff pleaded that the marketing material did not adequately disclose the existence of the inherent defects, the failure defects, the risk of adverse events and/or the removal limitation. Further and better particulars to that paragraph include:
(a)Marketing material relating to the Essure Device published by Bayer in the USA contained more disclosures as to the adverse events than material published in Australia at the same time. (See e.g. the 2004 patient information brochure in Australia (BHC.001.001.0257) containing less discussion of risks than the 2004 patient information brochure in the US (BAYEDPA-0391887R_0001)).
(c)The Defendants did not promptly update warning statements in line with the changes previously implemented in the USA despite repeated communications from the TGA. For details see Joint Expert Report from the Regulatory and Clinical Data Conclave (Question 1) (Regulatory JER Q1) dated 13 December 2022 at paragraph 27(b)(i); Expert Report of Kea Dent filed 30 May 2022 (Dent Primary Report) at paragraphs 4.3 item 10, 7.3.4, 7.5.3; Reply Report of Kea Dent filed 17 October 2022 (Dent Reply Report) at paragraph 3.11.3.
The Bayer and AMSL defendants submitted that the particulars should not be allowed if they were intended to introduce an independent and new basis upon which it was alleged the Essure device contained a defect or deficiency that had not previously been pleaded. They argued a comparative case between Australian and overseas materials had not previously been pleaded, and would necessarily require consideration of a range of matters in evidence, including comparison of the regulatory regimes in different jurisdictions and how those regimes operated to impose obligations to publish certain matters at different times.
The plaintiff is not seeking to make a ‘comparative case’. She simply relies on the documents as evidence illustrating the defendants’ knowledge of matters disclosed in the US material and their capacity to disclose such matters in the marketing material. The defendants do not object to that course.
The plaintiff seeks to rely on the Therapeutic Goods Administration (‘TGA’) communications for a similar purpose. Further, those communications have been the subject of consideration and opinion by both parties’ regulatory experts.
The Bayer and AMSL defendants submitted the particulars were impermissibly imprecise. The plaintiff offered to resolve that complaint by providing in a matter of days a table identifying precisely the USA marketing material and the relevant matters disclosed in that material as to the existence of the inherent defects, the failure defects, the risk of adverse events and/or the removal limitation. The plaintiff also agreed to identify each of the TGA communications. The plaintiff’s offer probably extends beyond the provision of particulars to the identification of evidence that would be relied on at trial. However, I concluded it was an appropriate course to adopt in order to address the Bayer and AMSL defendants’ concerns.
Paragraph 57
In paragraph 57 of the ASOC the plaintiff pleaded it was reasonably foreseeable that loss or damage would be suffered by her and group members as a result of the inherent defects, the failure defects, the risk of adverse events and/or the removal limitation. The plaintiff also relies on this pleading to establish knowledge or constructive knowledge on the part of the defendants.
The plaintiff has now provided very extensive further and better particulars of the foreseeability/knowledge allegations.
Particular (p) to paragraph 57 reads in part:
As to the level of risk which was known or ought to have been known by the Defendants, the Plaintiff refers to the following facts which demonstrate that the level of risk identified in tests, studies, trials or reporting was or likely was underestimated, or there was a significant risk that it was underestimated:
(ii)tests, studies or trials relating to the Essure Device produced data:
A.which was not correctly analysed (see e.g. BAY-EDPA-2018696, BAY-EDPA2018926; see also Regulatory JER Q2 and Q3 at pp 13-17);
B.which indicated the occurrence of adverse events but which were misreported by the Bayer Defendants as though such events had not occurred (see e.g. BAY- EDPA-0654302, BAY-EDPA-0387303, BAY-EDPA-1536321, BAY-JCCP6086268).
(iv)identified risks were:
A.depressed by a desire to avoid adverse public perception (BAY-EDPA0735772);
B.otherwise consciously under-stated (see e.g. BAY-JCCP-0279674);
The Bayer and AMSL defendants submitted that particular (p) did not identify the risk being referred to, which of the defendants had actual constructive knowledge of the risk, and at what time.
In paragraphs (i) to (n) of the particulars, the plaintiff set out risks associated with implantation of the device which she alleges were foreseeable and/or were known or ought to have been known by each of the defendants. In many instances the plaintiff has identified the documents she will rely on as evidence of the particularised risks. Particular (p) is directed to the degree or level of the risks identified in particulars (i) to (n). Documents identified in the particulars include clinical trials, studies, reports and risk analysis conducted or prepared by the defendants. As to actual and constructive knowledge, the plaintiff relies on the identified documents and other facts particularised, the role of each of the defendants in relation to the Essure device pleaded elsewhere in the ASOC, and the corporate relationships and corporate history shared by the defendants. I accept the plaintiff’s submission that it is not necessary that she identify the precise parts of the identified documents that are said to make out her pleaded case. Read in context, particular (p) puts the Bayer and AMSL defendants sufficiently on notice of the case made against them in relation to the degree or level of the alleged risks.
The plaintiff goes further in particulars (p)(ii) and (iv) by alleging that the defendants misreported or under-reported risks consciously and for particular purposes. Allegations of this nature seem unnecessary to the matters sought to be established as set out in particular (p). If the plaintiff wishes to make that case, it would be necessary for her to plead the material facts and particulars of the allegations. The Bayer and AMSL defendants would then need to be afforded an opportunity to investigate the allegations, plead to them, and file and serve evidence in response. There is a good chance that process would interfere with the current timetable and possibly the trial date.
For these reasons I concluded particulars (p)(ii) and (iv) to paragraph 57 should not be allowed in their current form. I gave the plaintiff the opportunity to replead those particulars.
Paragraphs 70, 72, 83, 85, 94, 95, 105, 112 and 113
In the ASOC the plaintiff pleaded that the standard of care owed to women who had already had the Essure device implanted included disclosing to them information about the inherent defects, the failure defects and the risk of adverse events as that information became available, and that the defendants breached their duty of care by failing to do so. The plaintiff alleges that as a result of that breach the plaintiff and group members who had received the Essure device delayed taking action to address the harm and thereby suffered further harm.
In support of these allegations the plaintiff sought to rely on further and better particulars that reasonableness required the defendants to maintain a register of all patients in whom an Essure device had been implanted as a means of enabling them to give those patients information about risks associated with the device, and that the failure to maintain a patient register was a breach by the defendants of the duty owed to group members.
The only reference in the exchanged evidence to a patient register is in three short paragraphs of the reply report of statistician Professor Gordon filed by the plaintiff on 17 October 2022. The question that Professor Gordon was responding to related to observations by two of the defendants’ experts about the use of global data registries and databases to identify long-term safety issues which may arise with medical devices. Answering the question, Professor Gordon said:
406.I agree there is utility in maintaining a register of all patients in whom a device is implanted. I regard it as strongly desirable to do so.
407.A register of patients supports the prospective collection of data about 2770 treatment implementation and well-defined outcomes. Well-designed registries have the potential to provide long-term surveillance data.
408.Such a registry can provide information about positive and adverse health events for the patients who have received a particular intervention.
The plaintiff now seeks to rely on that brief comment from Professor Gordon as the foundation of an allegation that a patient register should have been maintained. The allegation is not as straightforward as it may seem. I understand that the Bayer and AMSL defendants did not supply devices directly to recipients. The practicality of maintaining a patient register when the device was supplied and implanted by third party providers has not been the subject of any evidence. Nor is there evidence about industry practices or regulatory requirements that may be relevant to maintaining a patient register. The particulars do not say whether the requirement ought to have applied only in Australia, or to every jurisdiction where the device was used. If this allegation were allowed, the defendants would need to be given the opportunity to investigate the matter, file and serve lay evidence, and potentially brief their experts to provide relevant opinions. Taking those steps at this stage risks interference with the timetable and the trial date. That course is not justified, particularly where the allegation is based on such limited material.
The plaintiff does not have leave to rely on the patient register particulars.
Conclusion
Orders have been made in accordance with these reasons.
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