Thompson v Rosen

Background

1. By statement of claim filed 1 November 2018, the plaintiff alleges that the first defendant, Dr David Rosen, was negligent in performing a hysterectomy, pelvic floor repair, paravaginal repair and cystoscopy on 28 August 2007. The plaintiff alleges that the second defendant, Associate Professor Lam, was negligent in managing a vaginal prolapse by inserting anterior PROLIFT® mesh and posterior Surgisis® mesh on 25 February 2008. I have set out the background in more detail in my earlier judgment: see Thompson v Rosen [2020] NSWSC 356 at [3]-[11].

The law

1. In accordance with s 64 of the Civil Procedure Act 2005, the Court may, at any stage of the proceedings, grant a party leave to amend any document in the proceedings. It relevantly reads: "64 Amendment of documents generally (1) At any stage of proceedings, the court may order- (a) that any document in the proceedings be amended, or (b) that leave be granted to a party to amend any document in the proceedings. (2) Subject to section 58, all necessary amendments are to be made for the purpose of determining the real questions raised by or otherwise depending on the proceedings, correcting any defect or error in the proceedings and avoiding multiplicity of proceedings. …"
2. The Court's power under s 64 is to be exercised in accordance with the overriding purpose of the Civil Procedure Act and the dictates of justice as set out in ss 56-58, which are well-known and need not be reproduced here.
3. In Colombini v De Berigny [2021] NSWSC 374 [81] the Court summarised the principles that apply to a proposed amendment of insufficient prospects of success: "Leave will not be granted to allow an amendment if it would be liable to be struck out had it appeared in the original pleading (see Horton v Jones (No 2) [1939] NSWStRp 35; (1939) 39 SR (NSW) 305 at 310; McGuirk at [18]). Leave to amend will, therefore, not be granted in respect of a pleading, or amendment, likely to be struck out as embarrassing (Tamaya Resources Ltd (in Liq) v Deloitte Touche Tohmatsu (a Firm) [2015] FCA 1098 at [142]- [143] per Gleeson J; Caason Investments Pty Ltd v Cao (2015) 236 FCR 322; [2015] FCAFC 94 at [21] per Gilmour and Foster JJ; ACN 074 971 109 v The National Mutual Life Association of Australasia Ltd[2010] VSC 186 at [29] per Croft J; Research in Motion Ltd v Samsung Electronics Australia Pty Ltd (2009) 176 FCR 66; [2009] FCA 320 at [21], [23] per Kenny J). In HFPS Pty Ltd (Trustee) v Tamaya Resources Ltd (in Liq) (No 2) [2016] FCA 446, for example, Foster J said (at [56]) that "[i]t would be a wrong exercise of the Court's discretion to allow an amendment for which there was no arguable basis in fact"."
4. Finally, the plaintiff referred to Aon Risk Services Australia Ltd v Australian National University (2009) 239 CLR 175 [111] the Court identified: "An application for leave to amend a pleading should not be approached on the basis that a party is entitled to raise an arguable claim, subject to payment of costs by way of compensation. There is no such entitlement. All matters relevant to the exercise of the power to permit amendment should be weighed. The fact of substantial delay and wasted costs, the concerns of case management, will assume importance on an application for leave to amend. Statements in J L Holdings which suggest only a limited application for case management do not rest upon a principle which has been carefully worked out in a significant succession of cases. On the contrary, the statements are not consonant with this Court's earlier recognition of the effects of delay, not only upon the parties to the proceedings in question, but upon the court and other litigants. Such statements should not be applied in the future."

The proposed amendments

1. Both defendants have deleted their earlier claims under the Limitation Act 1969 (NSW) and abuse of process.

Scope of duty of care

1. The paragraphs in dispute are [24]-[31] of Dr Rosen's proposed defence and [26]-[32] of Associate Professor Lam's proposed defence. These are the paragraphs that plead the scope and content of duty of care. Both proposed amendments are similar but not identical.

Dr Rosen's proposed amendments

1. Dr Rosen's amendments are set out at paragraph [24]-[31] of the proposed amended defence. They read: "Scope of Duty 24 On 25 February 2008 the plaintiff underwent surgery carried out by the second defendant at St George Private Hospital (Second Surgery), Particulars a. The Second Surgery was carried out using, inter alia, the medical device Gynecare PROLIFT Pelvic Floor Repair System (Anterior) manufactured by Ethicon Sari (PROLIFT device). 25 At the material time the PROLIFT Device was approved for use in Australia by the Therapeutic Goods Administration (TGA) for inclusion on the Australian Register of Therapeutic Goods: 26 At the material time, the first defendant did not know that the plaintiff intended to undergo surgery of the precise nature of the Second Surgery. 27 At the material time, the first defendant did not know that the PROLIFT device was to be used in the course of carrying out the Second Surgery, 28 At the material time, the PROLIFT device was defective and/or not fit for purpose. 29 At the material time, the first defendant did not know that the PROLIFT device was defective and/or not fit for purpose. 30 In answer to the whole of the statement of claim, the first defendant says that the scope of the duty owed by him to the plaintiff did not extend to the harm caused by the subsequent proper use in the Second Surgery of medical devices including the PROLIFT device being a device: a which was approved for use in Australia by the TGA for inclusion on the Australian Register of Therapeutic Goods; and b which unknown to the first defendant was defective and/or not fit for purpose. 31 Further, in answer to the whole of the statement of claim, in the event that the first defendant was in breach of his duty to the plaintiff (which is denied), the first defendant says that the plaintiff's alleged injury, loss and damage was caused by the PROLIFT device."

Associate Professor Lam's proposed amendments

1. Associate Professor Lam's amendments are set out at paragraph [26]-[33] of the proposed amended defence. They read: "Scope of Duty 26 On 25 February 2008 the plaintiff underwent surgery carried out by the second defendant at St George Private Hospital (Second Surgery). Particulars 27 The Second Surgery was carried out using, inter alia, the medical device Gynecare PROLIFT Pelvic Floor Repair System (Anterior) manufactured by Ethicon Sari (PROLIFT device). 28 At the material time the PROLIFT Device was approved for use in Australia by the Therapeutic Goods Administration (TGA) for inclusion on the Australian Register of Therapeutic Goods. 29 At the material time, the PROLIFT device was defective and/or not fit for purpose. 30 At the material time, the second defendant did not know that the PROLIFT device was defective and/or not fit for purpose 31 In answer to the whole of the statement of claim, the second defendant says that the scope of the duty owed by him to the plaintiff did not extend to the harm caused by the proper use in the Second Surgery of the PROLIFT device being a device. a which was approved for use in Australia by the TGA for inclusion on the Australian Register of Therapeutic Goods, and b which unknown to the second defendant was defective and/or not fit for purpose 32 Further, in answer to the whole of the statement of claim, in the event that the second defendant was in breach of his duty to the plaintiff (which is denied), the second defendant says that the plaintiff's alleged injury, loss and damage caused by the PROLIFT device which was defective and/or not fit for purpose."
2. The parties referred to several passages contained in the report of Professor Peter L Dwyer, a urogynaecology and reconstructive gynaecologic surgeon, dated 19 August 2019 (the Dwyer report). "Ms Thompson underwent a laparoscopic hysterectomy, anterior and posterior paravaginal repair and colposuspension on 28 August 2007 performed by Dr David Rosen. On 23 November 2007 she was referred to Professor Alan Lam with urogynaecological symptoms for a second opinion. Professor Lam subsequently performed an anterior vaginal wall repair with a J &J Prolift device using a polypropylene synthetic mesh to re- enforce the anterior vaginal wall repair. A posterior vaginal wall repair was also performed re-enforced with a Surgisis graft on 25 February 2008. … In my opinion Professor Lam provided a reasonable standard of skill and care in his management of Ms Thompson. Ms Thompson consulted with Professor Lam on a number of occasions prior to her surgery with him. From the documentation you provided it would appear he had extensive discussion regarding the surgery with her and the relative benefits and risks of the procedure. He also provided written documentation regarding this for her to read. The procedure of vaginal repair with Prolift mesh for the anterior wall prolapse and cystocoele and posterior wall repair reinforced with Surgisis appeared to be performed in a standard fashion and were frequently used by Gynaecologists to treat these problems at that time (1). … Please advise whether in his treatment of Ms Thompson Professor Lam acted in a manner that was widely accepted in Australia by peer professional opinion as competent professional practice, at the time that the service was provided namely in 2008. To address this question I refer to an article titled "Survey of Current Management of Prolapse in Australia and New Zealand" published by Vanspauwen et al (1). This was a postal questionnaire containing questions of four prolapse case scenarios and was sent to Australia and New Zealand Gynaecologists in mid 2007. Results were compared to a similar survey conducted in the U.K in 2006 (2). I have referenced this article by Vanspauwen et al and enclosed a copy with this report. In 2007 the procedure of choice for uterovaginal prolapse with the uterus in situ was a vaginal hysterectomy and vaginal repair. A graft was used by 13% of Gynaecologists for primary repair (no previous prolapse surgery) and in 61% of Gynaecologists for recurrent prolapse with most gynaecologists preferring a permanent synthetic mesh. For recurrent anterior vaginal prolapse the procedures of choice for Gynaecologists in Australia and New Zealand was vaginal repair reinforced with synthetic mesh in over 75%. In the United Kingdom 34% of Gynaecologists would reinforce their repairs with a graft for recurrent cystocoele such as Ms Thompson had. Therefore the procedures performed by Professor Lam in early 2008 were widely accepted and used in Australia by peer professional Gynaecologists. This was also the case internationally." (citations omitted)
3. Dr Dwyer is a reviewer of 12 international journals and is the author of an extensive number of peer reviewed articles as set out in his curriculum vitas at CB 51-86.

The defendants' submissions

1. Both defendants submitted that the content of their duty did not extend to the harm caused by the proper use of an approved medical device which, unknown to the first defendant, was defective and/or not fit for purpose. Further, the defendants say that in the event that they were in breach of their duty to the plaintiff (which is denied), the scope of liability does not extend to the plaintiff's injury, loss and damage as such loss was not caused by the defendants but by the approved medical device namely the Prolift device.
2. There is a basis for arguing the allegations contained in the proposed amendments. The Prolift device was designed, marketed and approved for use as a total, anterior and posterior pelvic floor repair system for tissue reinforcement and long-lasting stabilisation of fascial structures of the pelvic floor in vaginal wall prolapse.
3. On 30 March 2005, the Therapeutic Goods Authority approved the device for inclusion on the Australian Register of Therapeutic Goods and for its use.
4. Following its approval, the PROLIFT device was used by gynaecologists in Australia to treat patients presenting with signs and symptoms consistent with those suffered by the plaintiff. On 25 February 2008 the device was used by the second defendant in the course of carrying out surgery on the plaintiff.
5. The nature of the proposed amendments goes to relevant and real issues in the proceedings. First, the proposed amendments go to the question of the duty of care owed to the plaintiff by each of the defendants. There is a real issue as to whether the content of the respective duties extended to harm caused by the proper surgical use of a duly approved medical device - the Prolift device.
6. Before breach of duty may be assessed, the precise content of the duty owed should be determined. In Roads and Traffic Authority of NSW v Dederer (2007) 234 CLR 330 at [43], Gummow J stated: First, duties of care are not owed in the abstract. Rather, they are obligations of a particular scope, and that scope may be more or less expansive depending on the relationship in question. Secondly, whatever their scope, all duties of care are to be discharged by the exercise of reasonable care. They do not impose a more stringent or onerous burden."
7. The starting point for the analysis of breach of duty is the determination of the content of duty of care. Identification of the risk of harm is necessary before one can proceed to ascertain foreseeability, and the appropriate response to the risk.
8. From the viewpoint of the respective defendants, a determination that the content of the duty did not extend to harm caused by the proper use of a duly approved surgical device is a significant issue. The question of the content of the duty is a legal one based upon the existence of objective facts which underlay the allegations in the proposed amendments.
9. Secondly, the proposed amendments go to the issue of causation. The proposed amendments go to the issue of whether, in accordance with s 5D(1)(b) of the Civil Liability Act 2002 (NSW), a finding that the defendants' failure to exercise reasonable care causing harm to the plaintiff requires a determination that it is appropriate for the scope of liability to extend to that harm.
10. The nature of the proposed amendments should not take the plaintiff by surprise. First, and perhaps most obviously, the plaintiff was a former class member of the class action in the Federal Court. Secondly, on 19 October 2020 the second defendant served expert medical opinion stating the Prolift surgical mesh was in widespread use in Australia at the relevant time. Thirdly, on 11 February 2021 the second defendant served expert opinion to the effect that failure of the surgical use of the Prolift surgical mesh was a consequence not of the second defendant's conduct but of complications associated with the Prolift mesh itself.
11. The plaintiff claims that she has suffered injury, loss and damage as a consequence (in part at least) of the use of the Prolift device. Concurrently with the subject proceedings, the plaintiff was a class member of the class action proceedings. The Prolift device was also subject of the class action proceedings. In these circumstances, favour should not be given to the notion that the plaintiff is caught unawares or taken by surprise by the relationship between the Prolift device and the injuries and disabilities the plaintiff complains of.

Prejudice

1. In the event that leave to amend is granted, the defendants submitted that the plaintiff will not be unduly prejudiced.
2. The future procedural conduct of the matter should not be significantly disrupted by allowing the proposed amendments. No trial date has been set. There arises no need to vacate a hearing date or adjourn a trial. To the extent that the plaintiff may need to obtain further evidence to meet the proposed allegations, there is ample time to do so.
3. The defendants recognise that the overriding purpose of achieving a just resolution does not mean that a party is to be permitted to raise any arguable case at any point in the proceedings, on payment of costs. That said, it is submitted that upon a fair consideration of all of the circumstances of the defendants' application, the court would exercise its discretion in favour of allowing the proposed amendments to the defendants' respective defences.
4. The defendants submitted that to the extent that prejudice caused by delay is visited on the plaintiff, the prejudice is not of an undue or incurable nature. Certainly, any prejudice is not so great as to result in leave to amend being refused.
5. It would be unreasonable to argue that amendment to the respective defences could not have been made at an earlier time. The delay in amending the defences, however, is explicable when one has regard to the procedural history of the subject proceedings and the plaintiff's at times concurrent involvement in these proceedings and the class action proceedings.
6. Finally, the defendants submitted that even in the event that there is an inadequate explanation for the delay, such circumstance will not of itself preclude a favourable exercise of the discretion. In Voitenko v Zurich Australian Insurance Ltd [2019] NSWCA 229, Meagher and McCallum JJA at [30] held: "Where a court is required to exercise a discretion, the proper approach is to identify all of the relevant factors, obviously including any relevant mandatory considerations, and to weigh all of those factors in order to reach a conclusion as to how the discretion should be exercised. To exclude any individual consideration on the grounds that it alone does not warrant the relief sought would be a wrong approach."

The plaintiff's submissions

1. The plaintiff accepts that in a late application to amend a pleading a consideration is prejudice to the party seeking the amendment, but the plaintiff says that consideration does not have determinative weight. Rather, matters such as delay, wasted costs and concerns of case management are to be weighed, and assume importance in the application for leave to amend.
2. The plaintiff accepts that in a pleading dispute, the question of whether the impugned pleading reveals a reasonable defence proceeds on the alleged facts being accepted as true, and, subject to the exercise of discretion to permit a late amendment, whether the impugned defence has the quality of being liable to be struck out only if it reveals no reasonable prospect of success.
3. The plaintiff does not suggest that the current proposed amendments are capable of being cured by a revised, more considered, articulation in a further pleading.
4. The plaintiff's complaint is that the legal notions presented by the proposed pleading cannot properly be considered of sufficiently arguable merit in this case as it is too doubtful that the proposed pleading can be successful, and that situation, because of the disruption to the proceedings does not warrant the granting of leave to file the proposed amendment and the proposed pleading should not be allowed.
5. In oral submissions, the plaintiff recognised that the duty of care as pleaded in the amended defence is a triable issue and that opens the door that "they should be able to litigate it, … but then it becomes an issue of discretionary exercise...". The discretion should be exercised against the plaintiff because of the "discretionary exercise and the grafting of this massive additional forensic issue and the triable issues is sufficiently weak" (T10.37).
6. The plaintiff submitted that, despite the class action being decided, there is still a significant forensic debate as to the knowledge of the surgeons. The plaintiff will need to obtain a device report which is particularly costly (T21.5-15).
7. In submissions in reply, counsel for the defendants submitted that it "would be unreasonable to say that the amendments could not have been made earlier. However, the practical reality of the situation is that this has brought the situation into stark focus and that has led not just to the application in relation to the proposed amendments which are contested between the parties and also the proposed amendments which are not in contest between the parties." (T22.10).

Consideration

1. The defendants have a forensic decision not to cross claim against the manufacturer of the Prolift surgical devices. In my view, the defendants' proposed amendments raise triable issues and go to the real issues in dispute. So far as prejudice is concerned, no trial date has been set, I accept the amendments may result in the plaintiff needing to obtain an expert report covering topics such as these devices and the professions' knowledge of any defects from 2005 and 2008. Professor Dwyer refers to journal reports covering the use of the devices in 2007 and refer to numerous peer review articles published on this topic. In considering these factors and in the exercise of my discretion, it is my view that justice is best served if the defendants are permitted to rely on their proposed amendments. I grant leave to the defendants to file and serve their amended defences within 14 days of the 14 June 2021.

Costs

1. The defendants accept that the appropriate costs order is that the defendants pay the costs of the motion and any costs thrown away by the amendments. In my view this is the appropriate order. I make this order.

The Court orders that: 1. The first and second defendants are to file and serve amended defences on or before 29 June 2021. 2. The first and second defendants are to pay the costs of the notice of motion filed 11 March 2021 and the costs thrown away by the amendments.

DISCLAIMER - Every effort has been made to comply with suppression orders or statutory provisions prohibiting publication that may apply to this judgment or decision. The onus remains on any person using material in the judgment or decision to ensure that the intended use of that material does not breach any such order or provision. Further enquiries may be directed to the Registry of the Court or Tribunal in which it was generated. Decision last updated: 15 June 2021