FEDERAL COURT OF AUSTRALIA

Stanford v DePuy International Ltd (No 3) [2015] FCA 325

THE COURT ORDERS THAT:

1.    The penultimate sentence of paragraph 93 of the third affidavit, sworn 5 February 2015, of Professor Graves be admitted.

2.    The balance of paragraphs 90 to 93 of the third affidavit, sworn 5 February 2015, of Professor Graves be rejected.

Note:    Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

REASONS FOR RULINGS

1    The respondents object to the whole of [90]-[93] of the third affidavit of Professor Stephen Graves, dated 5 February 2015. The objection is made primarily because, the respondents contend, the basis of the material is not disclosed or proved; the underlying data are not provided; and the assertions made by the witness cannot be tested. The respondents submit that it would be unfair for the paragraphs to be admitted in those circumstances.

2    Professor Graves is the Director of the Australian Orthopaedic Association National Joint Replacement Registry (the Registry). An issue in the case is the relevance to the failure of the implants of the relevant surgeon’s surgery experience and technique. The paragraphs objected to go largely to that issue. More specifically, the paragraphs deal with Professor Graves’ opinion as to why he considers the high revision rate for the ASR resurfacing was not related to learning curve.

3    In [90]-[93], Professor Graves provides detailed numbers and figures relating to revision rates at three unnamed hospitals. It is common ground that the paragraphs do not set out the raw data underlying Professor Graves’ analysis.

4    On 2 April 2015 I gave a preliminary indication that the underlying data should be provided by the applicants to the respondents. When the matter was the subject of argument on 7 April 2015, the applicants submitted that the raw data are not able to be disclosed, including by way of production to the Court, due to the Registry’s role in carrying out declared quality assurance activities under s 124Y of the Health Insurance Act 1973 (Cth). I have been provided with a copy of the Minister’s declaration, by way of legislative instrument, of the Registry as providing a declared quality assurance activity under s 124X of the Health Insurance Act.

5    The terms of s 124Y are as follows:

124Y    Information about declared quality assurance activity not to be disclosed

(1)    Subject to this section, a person who acquires any information that became known solely as a result of a declared quality assurance activity, whether the person acquired the information in the course of engaging in that activity, as a result of a disclosure under section 124Z or in any other way, must not, except for the purposes of that activity or in accordance with an authority given by the Minister, directly or indirectly make a record of that information or disclose that information to another person or to a court.

Penalty: Imprisonment for 2 years.

(2)    Subject to this section, a person cannot be required:

(a)    to produce to a court a document that was brought into existence solely for the purposes of a declared quality assurance activity; or

(b) to disclose to a court any information that became known solely as a result of such an activity;

except when it is necessary to produce the document or disclose the information for the purposes of this Part.

(3)    Subsections (1) and (2) do not apply to information that does not identify, either expressly or by implication, a particular individual or particular individuals.

(4)    Subsection (2) does not apply to a document that does not identify, either expressly or by implication, a particular individual or particular individuals.

(5)    This section does not prohibit a disclosure of information if the person, or each of the persons, who would be directly or indirectly identified by the disclosure consents to that disclosure of the information.

(6)    This section does not prohibit the disclosure of information to the Minister for the purpose of enabling the Minister to decide whether to authorise the disclosure of the information under section 124Z.

(7)    If a quality assurance activity ceases to be a declared quality assurance activity, this section nevertheless continues to apply in respect of information that became known, or a document that was brought into existence, at a time when the activity was a declared quality assurance activity.

6    The provision appears to have been first introduced by the Health Insurance (Quality Assurance Confidentiality) Amendment Act 1992 (Cth) (Act No. 201 of 1992) as s 106M.

7    No judicial authority has been discovered by the researches of counsel. Certain administrative decision makers have referred to the provision, including: Jimmy Philip Yoo and Sir Charles Gairdner Hospital, Re [2009] WAICmr 10 and Watmore and WA Country Health Service - Great Southern, Re [2012] WAICmr 29. I have taken those decisions into account, so far as relevant. They do not seem to me to take the matter beyond the plain words of the section, to which I now turn.

8    Relevant definitions are set out in s 124W.

9    I am persuaded that s 124Y(1) applies and the giving of the evidence by this deponent is not within the expression “except for the purposes of that activity or in accordance with an authority given by the Minister”, but the real issue is the meaning and application of the opening words of that provision “Subject to this section … ”

10    Neither subsection (1) nor subsection (2) applies to information or to a document that does not identify, either expressly or by implication, a particular individual or particular individuals: see subsections (3) and (4).

11    In my opinion, it is too broad a proposition to say that disclosure of the data underlying the analysis would enable the identification of individual patients and may also identify individual surgeons and hospitals associated with the relevant procedures.

12    In my opinion, a hospital, as such, is not within the words “a particular individual or particular individuals” as, consistently with s 2B of the Acts Interpretation Act 1901 (Cth), “individual” means a natural person. Thus, it may be not be prohibited to disclose the names of the hospitals, although not where so to do would identify, either expressly or by implication, a particular individual or particular individuals. It may be that disclosure of the names of the three hospitals would identify by implication the names of the individual surgeons.

13    The material before me does not disclose whether an attempt has been made to redact from the raw data that material which would identify, either expressly or by implication, a particular individual or particular individuals, by which I mean, on present information, the patients and the surgeons. In my opinion, that is a necessary first step. That step should be taken and taken as soon as possible.

14    I do not shut out the respondents from then contending that there remains some unfairness to them in relation to their lack of capacity to test the material.

15    A further ground of objection to this material was that it was not opinion evidence of Professor Graves but an analysis apparently carried out by unidentified persons at the Registry. I do not reject the paragraphs on this ground as the respondents can test that proposition in cross examination. At present it seems to me that Professor Graves as Director of the Registry was responsible for the data to which he deposes in paragraphs [90]-[93] of his third affidavit.

16    I have already rejected the first 10 words or numerals of [90] as they refer to a subparagraph of the second affidavit by Professor Graves that was not read. I admit the penultimate sentence of [93] in so far as it is a reference back to paragraphs of that second affidavit which have been read.

17    I accept the respondents’ submission that, in effect, the level of detail in [90]-[93] would make it unfair to the respondents for the applicants to rely on it where the respondents are not able to have access to the raw data.

18    My ruling is that I reject the balance of [90]-[93], including Figures 4, 5 and 6. I will revisit that question if and when the data underlying the analysis has been provided to the respondents, that data to exclude any material which would identify, either expressly or by implication, a particular individual or particular individuals.

Associate:    

Dated:    8 April 2015