McGarry v Southern NSW Local Health Network

Application for leave to amend 8On 7 June 2013 the plaintiff served a proposed amended statement of claim and on 12 June 2013 she filed a notice of motion for leave to amend the statement of claim. A further iteration of the draft amended statement of claim was marked MFI 1 at the hearing of the application for leave to amend. MFI 1 is the draft which I considered for the purposes of the application for leave. 9The plaintiff relied on the following evidence in support of her application for leave to amend: (1)Affidavits of Geoffrey John Potter sworn 11 June 2013 and 9 August 2013; (2)Letter from plaintiff's solicitors to the second defendant's solicitor dated 8 August 2012 enclosing the Stryker report; (3)Operation report of 31 August 2010 in respect of the plaintiff. 10The second defendant relied on the affidavit of Jacqueline Anne-Marie Fox sworn 18 July 2013 which sets out the chronology of the proceedings and the service of reports. 11The draft amended statement of claim contains the following amendments: (1)Additional allegations of negligence against the first defendant; (2)Additional allegations of negligence against the second defendant; and (3)Joinder of a third defendant, Stryker, who manufactured the reamer broach. 12The first defendant does not oppose the filing of the amended statement of claim. The second defendant does not oppose the amendments except for the following allegations of negligence ([20]) and breach of contract ([21]) made against him: (g) Used excessive or inappropriate force in using the reamer broach. (i) Inappropriately used a flexible reamer when it constituted off label use. (j) Failed to use a taper pin reamer or gouge to further develop the femoral cavity. (k) Failed to record or adequately record the number of procedures for which the reamer broach was used. 13The second defendant does not oppose the amendment in so far as (h) is concerned, which alleges: "Failed to properly or adequately or sufficiently develop the femoral cavity such that an overly tight fit resulted." 14I note that these allegations are expressed to be particulars of negligence or particulars of breach of contract. However, they are, in substance, material allegations of fact and, as the parties have treated them as such, I shall treat them on the same basis. 15The plaintiff relied on expert reports and documents produced by Stryker on subpoena, including emails and the Stryker report, in support of the allegations referred to above and contended that she ought be permitted to amend her statement of claim accordingly. The second defendant contended that, on proper analysis, the documents relied upon either did not support the allegations or did not constitute an expert opinion or other sufficient basis for the allegation such as ought incline the Court to allow the amendment. He also submitted that, since the plaintiff had had ample opportunity to provide expert reports on liability, she ought not be allowed to amend in circumstances where the material served did not provide a basis for the proposed amendment. 16In my view it is not appropriate, at this stage of the proceedings, to allow an amendment to add an allegation of negligence when the allegation is not substantiated by any expert evidence or necessary inference from the evidence. The circumstances in the instant case are to be contrasted with the requirements for filing and service of expert reports in professional negligence claims when proceedings are commenced: UCPR 31.36. When proceedings are commenced, the threshold is lower; it is not necessary that an expert's report address each of breach of duty, damage and causation: Salzke v Khoury [2009] NSWCA 195; 74 NSWLR 580 (Salzke) at [61] per Ipp JA, Gzell J agreeing. Nor is it appropriate in those circumstances that an unduly technical approach be taken to the requirements of the rule which would have the effect of turning it into a obstacle to a plaintiff having his or her case determined on the merits: Salzke at [123] per Basten JA.

(g) Used excessive or inappropriate force in using the reamer broach 17The plaintiff relies on the following passage from the Stryker report to support allegations (g), (i) and (j): 6. Expanded Investigation Activities: Packaging Insert / Literature Review: Review of the surgical technique for implantation of the Exeter stem notes that "it is a serious mistake to over-rasp/broach the canal and remove too much cancellous bone. If excess force is required to introduce the rasp/broach to this level, a smaller rasp/broach should be used, or the canal should be further developed with the taper pin reamer or gouge, without compromising the layer of strong trabecular bone." There is a likelihood that the femoral cavity was not developed sufficiently or properly, resulting in an overly tight fit with the subject rasp. The complaint states a flexible reamer was used to ream the femur to 13mm. This constitutes off-label use since the surgical technique states a taper pin reamer or gouge is to be used to further develop the cavity. Additionally it was reported that the rasp handle used during the surgery was an Accolade Rasp Handle, catalog 1020-1400, which should be used in conjunction with a Slotted Mallet, catalog 1120-1000. When inserting the rasp, the strike plate of the rasp handle is impacted with the circular flat surface of the slotted mallet. During extraction, however, the mallet should be rotated 90 degrees. The thin portion of the rasp handle should be placed within the mallet slot. Impacting upward will extract the rasp in a way that more evenly loads the inferior face of the strike plate and the rasp. [Emphasis added.] 18Mr Blount, counsel for the plaintiff, conceded that there was nothing in the experts' reports to substantiate allegation (g). He relied exclusively on the passage from the Stryker report referred to above and in particular the part underlined. 19Mr Fordham SC, counsel for the second defendant submitted that it was telling that the plaintiff had had the Stryker report for about a year and had provided it to both of the specialist surgeons qualified for the purposes of the proceedings but that neither of them had given an opinion to support the allegation in (g). 20The extract from the Stryker report underlined above referred to the undesirability of removing too much bone from the canal and the prudence of using a smaller instrument if excessive force is required to introduce the rasp or broach to this level with a smaller implement. This comment, if it were adopted by an expert surgeon and linked with the second defendant's conduct in the instant case, might form a sufficient basis for the allegation to be pleaded. Having regard to the time that the proceedings have been on foot and the service by the plaintiff of its experts' reports on liability, the absence of such an opinion and such a nexus, means that the conclusion can more readily be reached that there is no basis for the allegation except speculation from an investigation report, the authorship of which is unknown, made on the basis of a foundation that is not clear. 21In these circumstances I refuse leave to add allegation (g).

(i) Inappropriately used a flexible reamer when it constituted off label use 22Mr Blount relied on the following passage from the Stryker report referred to above: The complaint states a flexible reamer was used to ream the femur to 13mm. This constitutes off-label use since the surgical technique states a taper pin reamer or gouge is to be used to further develop the cavity. 23In addition he relied on the following question and answer from Dr Ginsburg's report dated 20 June 2013: If a competent orthopaedic surgeon had observed that the canal was still tight while he was rasping out of the canal and prior to any stage of not being able to advance it further, ought a competent orthopaedic surgeon have not continued to use the rasp but instead used a smaller or different instrument to develop the canal further? Either to use a smaller rasp or enlarge the canal. 24Mr Fordham accepted that the passage in Dr Ginsburg's report supported allegation (h) to the extent that it formed a sufficient basis for it to be pleaded. He contended that it did not provide any basis for allegation (i). He submitted that the pleadings did not contain any allegation that the flexible reamer had broken. The relevant allegation is that the reamer broach had snapped. 25Although the allegation in (i) appears to have been derived from the Stryker report, there is no support in the pleadings for the allegation that use of the flexible reamer caused any harm to the plaintiff. Furthermore neither Dr Miller nor Dr Ginsburg have connected use of the flexible reamer with the plaintiff's harm or criticised the second defendant for his use of a flexible reamer. In these circumstances I refuse leave to amend to add allegation (i).

(j) Failed to use a taper pin reamer or gouge to further develop the femoral cavity 26The passage from the Stryker report relied on to support this allegation is: The complaint states a flexible reamer was used to ream the femur to 13mm. This constitutes off-label use since the surgical technique states a taper pin reamer or gouge is to be used to further develop the cavity. 27For the reasons already given with respect to allegation (i), leave to amend to add allegation (j) is refused.

(k) Failed to record or adequately record the number of procedures for which the reamer broach was used 28The plaintiff relied on an exchange of internal Stryker emails to support the allegation. The emails reveal concerns within Stryker about breakage of broaches after repeated use. Examples of such concerns are set out below: "For example reamers are on the radar because we know they get blunt eventually so they want to put some rules around the number of times the reamers should be used before being swapped out." (4 August 2011, 3.20 pm) "Obviously given the treatment these rasps get during every case and considering the number of cases performed per annum in this state the cause for the problem is metal fatigue. Do we know how old our rasps are and how often they are used?" (4 August 2011, 4.52 pm). 29The plaintiff also relied on a publication produced by Stryker on subpoena entitled "Instructions for Cleaning, Sterilization, Inspection and Maintenance" which includes, under the heading "Cleaning" on page 8, the following: "Functional checks should be performed at all times: . . . - Rotating instruments, such as multiple use drill bits, and reamers, should be checked for straightness. This can be achieved by simply rolling the instrument on a flat surface. . . . ." 30Mr Blount, counsel for the plaintiff, conceded that there was nothing in the experts' reports to substantiate allegation (k) against the second defendant. 31Dr Miller, in his report dated 7 August 2013, addressed the issue of proper equipment. His report specifically supported such an allegation being made against the first defendant. For example he said: "In regard to the proper equipment, this includes the availability of the necessary instruments and their necessary maintenance. It is the institution offering the service that monitors the instruments provided to the surgeon for the procedure. This includes keeping a record of the age, number of usages and the condition of the implements, such as a reamer broach. This would also cover the contingency that surgical instruments be replaced routinely based on their frequency of usage and their age. In Mrs McGarry's case it would appear that the reamer broach used in her operation had been in use for six years. It was [sic] would appear from the internal emails of the Stryker company that his instrument should have been replaced earlier. It is likely that instruments that are replaced according to recommendations are unlikely to fail. Visual inspection of instruments should be carried out by a surgeon prior to use to enable the surgeon to assess the instrument for defects. It is the institution's responsibility to inform the surgeon of the age of equipment, thus allowing him the option as to whether to proceed with the use of the item or arrange its replacement. These principles apply generally to all surgical procedures, independent of sub-speciality." 32According to the plaintiff's expert evidence on liability the only relevant obligation of the surgeon is to conduct a visual inspection. Dr Miller's opinion is that it is the hospital (in this case, the first defendant), not the surgeon, which is responsible for recording the number of procedures for which the implement has been used. There is no support for the allegation that the second defendant, as opposed to the first defendant, was responsible for recording the number of procedures for which the reamer broach was used. Indeed, the only expert evidence on the topic served by the plaintiff, which is set out above, is to the contrary. 33Accordingly leave is refused to add allegation (k). 34Because of the imminence of the expiry of the limitation period, Mr Blount asked that leave to replead be granted. He did not formulate any further allegations not included in the present draft pleading in respect of which leave was sought. Nor is it apparent that any of the objections to the paragraphs in respect of which leave to amend has been refused could be overcome by redrafting. In these circumstances, it is not appropriate to grant such leave. Accordingly leave to replead is refused.

Orders 35I make the following orders: (1)Grant leave to the plaintiff to file an amended statement of claim in the form of the document marked MFI 1, with the exception of the following paragraphs, in respect of which leave is refused: [20] (g), (i), (j) and (k) and [21] (g), (i), (j) and (k).

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: 14 August 2013