Invisalign Australia Pty Ltd v SmileDirectClub LLC

[2023] FCA 395

FEDERAL COURT OF AUSTRALIA

Invisalign Australia Pty Limited v SmileDirectClub LLC [2023] FCA 395

File number:

NSD 1356 of 2021

Judgment of:

ANDERSON J

Date of judgment:

5 May 2023

Catchwords:

CONSUMER LAW – misleading and deceptive conduct – where the applicant, Invisalign, supplies clear dental aligners to consumers in the market for teeth straightening treatments (Invisalign Aligner Treatment) – where the respondents (SDC) have engaged in promotional advertising in respect of its clear aligner teeth straightening products (SDC Aligner Treatment) – where the applicant alleges that representations that were made by SDC in promotion of its SDC Aligner Treatment is false, misleading or deceptive, or likely to mislead or deceive consumers pursuant to ss 18 and 29 of the Australian Consumer Law (Schedule 2 to the Competition and Consumer Act 2010 (Cth)) (ACL) – where the applicant alleges false or misleading representations were made by SDC in relation to the cost, efficacy and results achieved by SDC Aligner Treatment – comparative advertising – assessment of representations made by SDC against the principles in Gillette Australia Pty Ltd v Energizer Australia Pty Ltd [2002] FCAFC 223; 193 ALR 629 – whether the alleged representations were conveyed – whether the alleged representations were false, misleading or deceptive, or likely to mislead or deceive – where none of the applicant’s claims are made out – application dismissed with costs

CONSUMER LAW – cross-claim – where the cross-claimant, SDC, alleges that cross-respondent made various representations about SDC Aligner Treatment in an advertorial which was published by a media outlet (DIY article) which it alleges were false, misleading or deceptive, or likely to mislead or deceive – where the cross-claimant alleges that the DIY article as well as other promotional material published by Invisalign made false representations with respect to the comfort, predictability of treatment and the treatment time associated with Invisalign Aligner Treatment – application also dismissed with costs

Legislation:

Australian Consumer Law (Sch 2 to the Competition and Consumer Act 2010 (Cth)) ss 18, 29

Evidence Act 1995 (Cth)

Therapeutic Goods Administration Act 1989 (Cth)

Cases cited:

Australian Competition and Consumer Commission v Air New Zealand(No 1) [2012] FCA 1355; 207 FCR 448

Australian Competition and Consumer Commission v Australian Institute of Professional Education Pty Ltd (in liq) (No 2) [2018] FCA 1459

Australian Competition and Consumer Commission v TPG Internet Pty Ltd [2020] FCAFC 130; 278 FCR 450

AFT Pharmaceuticals (AU) Pty Limited v Reckitt Benckiser (Australia) Pty Limited [2020] FCAFC 45; 142 ACSR 522

AFT v Reckitt Pharmaceuticals (AU) Pty Ltd v Reckitt Benckiser (Australia) Pty Ltd [2020] FCA 672

Allianz Australia Insurance Ltd v Delor Vue Apartments CTS 39788 [2021] FCAFC 121; 396 ALR 27

AON Risk Services Australia Ltd v Australian National University [2009] HCA 27; 239 CLR 175

Australian Competition and Consumer Commission v Coles Supermarkets Australia Pty Ltd [2014] FCA 634

Australian Competition and Consumer Commission v Employsure Pty Limited [2021] FCAFC 142; 392 ALR 205

Australian Competition and Consumer Commission v Google LLC (No 2) [2021] FCA 367; 391 ALR 346

Australian Competition and Consumer Commission v Singtel Optus Pty Ltd (No 1) [2010] FCA 1177

Australian Competition and Consumer Commission v Telstra Corporation Ltd [2007] FCA 1904; 244 ALR 470

Australian Competition and Consumer Commission v TPG Internet Pty Limited [2013] HCA 54; 250 CLR 640

Browne v Dunn (1893) 6 R 67

Caason Investments Pty Ltd v Cao [2015] FCAFC 94; 236 FCR 322

Campomar Sociedad, Limitada v Nike International Ltd [2000] HCA 12; 202 CLR 45

Charan v Nationwide News Pty Ltd [2018] VSC 3

Dr August Wolff GmbH & Co. KG Arzneimittel v Coombe International Ltd [2020] FCA 39; 149 IPR 1

Gillette Australia Pty Ltd v Energizer Australia Pty Ltd [2002] FCAFC 223; 193 ALR 629

Global Sportsman Pty Ltd v Mirror Newspapers Pty Ltd [1984] FCA 167; 2 FCR 82

Google Inc v Australian Competition and Consumer Commission [2013] HCA 1; 249 CLR 435

Hanson Beverage Co v Bickfords (Australia) Pty Ltd [2008] FCA 406; 75 IPR 505

Hoover Australia Pty Limited v Email Limited [1991] FCA 646; 104 ALR 369

iNova Pharmaceuticals (Australia) Pty Ltd v Reckitt Benckiser (Australia) Pty Ltd [2018] FCA 1209

KTC v David [2022] FCAFC 60

Luxottica Retail Australia Pty Ltd v Specsavers Pty Ltd [2010] FCA 423

Polaris Communications Pty Ltd (ACN 006 102 601) v Dynamic Hearing Pty Ltd (ACN 098 876 212) [2009] FCA 890

Reckitt Benckiser (Australia) Pty Limited v AFT Pharmaceuticals (AU) Pty Limited [2018] FCA 1552

Reckitt Benckiser (Australia) Pty Ltd v Proctor and Gamble Australia Pty Limited [2018] FCA 378

Roach v Page (No 15) [2013] NSWSC 939

Rodney Jane Racing Pty Ltd v Monster Energy Company [2019] FCA 923; 142 IPR 275

Southern Cross Airports v Chief Commissioner of State Revenue [2011] NSWSC 347

Specsavers Pty Ltd v Luxottica Retail Australia Pty Ltd [2013] FCA 648

Taco Company of Australia Inc v Taco Bell Pty Ltd (1982) 42 ALR 177

Telstra Corporation Ltd v Optus Communications Pty Limited [1996] FCA 1035; 36 IPR 515

Telstra Corporation Ltd v SingTel Optus Pty Ltd [2007] FCA 824

Tobacco Institute of Australia Ltd v Australian Federation of Consumer Organisations Inc [1992] FCA 962; 38 FCR 1

TPG Internet Pty Ltd v Australian Competition and Consumer Commission [2012] FCAFC 190; 210 FCR 277

Federal Court of Australia, Expert Witness Practice Note (GPN-EXPT), 25 October 2016

Federal Court of Australia, Survey Evidence Practice Note (GPN-SURV), 25 October 2016

Division:

General Division

Registry:

New South Wales

National Practice Area:

Commercial and Corporations

Sub-area:

Regulator and Consumer Protection

Number of paragraphs:

1011

Date of hearing:

10-19 October 2022 and 14-15 November 2022

Counsel for the Applicant:

Ms K C Morgan SC with Ms J M Beaumont SC and
Ms J E McKenzie

Solicitor for the Applicant:

MinterEllison

Counsel for the Respondents:

Mr N De Young KC with Mr D Tynan and Ms T Epstein

Solicitor for the Respondents:

DLA Piper Australia

ORDERS

NSD 1356 of 2021

BETWEEN:

INVISALIGN AUSTRALIA PTY LIMITED (ACN 098 357 736)

Applicant

AND:

SMILEDIRECTCLUB LLC

First Respondent

SMILEDIRECTCLUB AUS PTY LTD (ACN 632 280 310)

Second Respondent

AND BETWEEN:

SMILEDIRECTCLUB AUS PTY LTD (ACN 632 280 310)

Cross-claimant

AND:

INVISALIGN AUSTRALIA PTY LIMITED (ACN 098 357 736)

Cross-respondent

ORDER MADE BY:	ANDERSON J
DATE OF ORDER:	5 MAY 2023

THE COURT ORDERS THAT:

1.The applicant be granted leave to file and serve the Amended Concise Statement in the form set out in Annexure A to the proposed minutes of order received by the Court on 31 October 2022.

2.The applicant’s claim be dismissed. 

3.The applicant pay the respondents’ costs of the claim, to be fixed by way of an agreed lump sum or, in default of agreement, by way of a lump sum fixed by a Registrar.

4.The cross-claimant’s cross-claim be dismissed. 

5.The cross-claimant pay the cross-respondent’s costs of the cross-claim, to be fixed by way of an agreed lump sum or, in default of agreement, by way of a lump sum fixed by a Registrar.

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

REASONS FOR JUDGMENT

ANDERSON J:

INTRODUCTION	[1]
RULINGS ON AMENDED CONCISE STATEMENT AND EVIDENCE	[14]
Invisalign’s Amended Concise Statement	[16]
Schedule 1 to Invisalign’s Closing Written Submissions	[22]
Rulings on objections to the evidence of Mr David Cristofaro	[43]
Section 69 Evidence Act – Business Records	[82]
Consideration of objections to Mr Cristofaro’s evidence	[85]
THE EVIDENCE	[93]
INVISALIGN’S EVIDENCE	[94]
Ms Karen McGoldrick	[95]
Evidence in chief	[95]
The Invisalign system	[103]
Registration of the Invisalign system in Australia	[106]
Invisalign treatment options	[109]
Training of doctors	[111]
Marketing and promotion of the Invisalign system	[114]
Cross-examination of Ms McGoldrick	[117]
Dr Bradley Stanley	[136]
Ms Jaimie Wolbers	[141]
Mr Jack Stanley	[145]
Dr Vicki Vlaskalic	[150]
Dr Eugene Chan	[155]
Mr Alan Scott MacLean	[159]
Evidence in chief	[159]
Cross-examination of Mr MacLean	[166]
Dr Marcus Tod	[175]
Evidence in chief	[175]
Cross-examination of Dr Tod	[180]
Professor Craig William Dreyer	[220]
Evidence in chief	[220]
Buschang Article	[224]
Gu Article	[228]
Miller Article	[235]
White Article	[244]
Cross-examination of Professor Dreyer	[259]
Ms Monina Tanya Rivera	[269]
Invisalign vs Braces webpage	[274]
Grid of photographs and quotations	[277]
Facebook posts	[284]
Ms Georgia Louise Holt	[294]
Ms Janelle Pyne	[310]
SDC’S EVIDENCE	[326]
Ms Niki Brown	[327]
Evidence in chief	[329]
SDC Australia website	[330]
Smile Assessment webpage	[331]
Pricing on the SDC Australian Website	[337]
“Up to 60% less than braces” claim on the SDC Australian Website	[339]
SDC’s “Lifetime Smile Guarantee”	[347]
Other statements on the SDC Australia Website	[350]
SDC Australia Social Media	[355]
Advertorials	[359]
Examination in chief of Ms Brown	[360]
Cross-examination of Ms Brown	[362]
Dr Jeffrey Sulitzer	[405]
Evidence in chief	[407]
Treatment with SDC aligners	[412]
SmileShops	[416]
Impression kits	[419]
SDC Customer Care Team	[421]
Pre-Screening and Creation of the Draft Treatment Plan	[423]
Evaluation by Affiliated Dentists	[427]
Treatment process	[433]
Cross-examination of Dr Sulitzer	[443]
Dr Hendrik Lai	[501]
Evidence in chief	[502]
Cross-examination of Dr Lai on day 3	[527]
Further cross-examination of Dr Lai on day 11	[544]
Dr Derek Roy Mahony	[562]
Mr David Daniel Cristofaro	[568]
Evidence in chief	[570]
Cross-examination of Mr Cristofaro	[587]
Mr Greg Bodulovic	[613]
Dr Marc Bernard Ackerman	[617]
Evidence in chief	[618]
Cross-examination of Dr Ackerman	[630]
JOINT EXPERT REPORT AND EXPERT CONCLAVE	[646]
Relevant experience of the experts	[650]
Terminology	[655]
Limitations of clear aligner therapy	[658]
Diagnostic assessment of patients	[665]
Pre-programming of clear aligners	[674]
Role of general dentists in diagnostic assessment of patients	[678]
Suitability of treatment	[681]
Monitoring of patients receiving clear aligner therapy	[692]
Treatment time	[697]
Comfort	[698]
RELEVANT PRINCIPLES	[699]
False, misleading or deceptive representations	[699]
Comparative advertising	[718]
CONSIDERATION OF INVISALIGN’S CLAIM	[731]
FALSE, MISLEADING OR DECEPTIVE CLAIMS	[733]
Total Cost Representation	[733]
Item (a) – “SDC Website Homepage”	[739]
Item (b) – “SDC AU Pricing Page”	[740]
Item (c) – Advertorial in Marie Claire Magazine	[741]
Item (d) – Advertorial in Women’s Health Magazine	[742]
Discussion	[743]
Less than $4 a day Representation	[778]
Discussion	[785]
Comprehensive Solution Representation	[799]
Discussion	[803]
COMPARATIVE ADVERTISING CLAIMS	[815]
Price Comparison Representations	[819]
“Up to 60% less than” claim	[825]
“60% less than” claim	[831]
Discussion	[837]
Comparable Treatment Representation	[873]
Discussion	[874]
Lower Cost Representation	[883]
Discussion	[887]
OUTSTANDING ISSUES ON THE SUBSTANTIVE CLAIM	[891]
CONSIDERATION OF THE CROSS-CLAIM AGAINST INVISALIGN	[893]
Representations alleged to have been made by Invisalign in the DIY article	[898]
DIY article	[901]
SDC’s contention that the “representations” were made by Invisalign	[907]
Implied reference to SDC not made out	[915]
Alleged Treatment Time Representation	[932]
Organic Content Representation	[973]
Comfort Representations	[981]
Predictability Representation	[1002]
DISPOSITION	[1009]

INTRODUCTION

1. The applicant (Invisalign) and the respondents (collectively, SDC) are competing providers of clear aligner teeth straightening products in Australia.  Invisalign alleges that SDC has engaged in false, misleading or deceptive conduct in relation to certain promotional material that it has published with respect to its clear aligners (SDC aligners).  The promotional material that is the subject of Invisalign’s claim is listed in Annexure A to the Concise Statement (CS), which was later amended under Annexure A to the Amended Concise Statement (Amended CS).  This promotional material was then further particularised in Schedule 1 to Invisalign’s closing submissions, which is annexed to these reasons for judgment at Annexure C. 

2. The second respondent (SDC AU) has brought a cross-claim against Invisalign.  SDC AU alleges that Invisalign has published or caused to be published material which is false, misleading or deceptive.

3. Both the claim and cross-claim are brought pursuant to ss 18 and 29 of the Australian Consumer Law (Schedule 2 to the Competition and Consumer Act 2010 (Cth)) (ACL).

4. This dispute revolves around two companies that offer clear aligner teeth straightening treatment. 

5. Invisalign commenced operating in Australia in late 2001 and was the first supplier of clear aligners in Australia.  SDC commenced operating in Australia from about 29 May 2019. 

6. Clear aligners are teeth straightening products that are designed to gradually move and straighten a patient’s teeth over the course of a number of months.  Clear aligners are seen as an alternative to braces and take the form of subtle, transparent mouthguards that are custom fit to each patient’s teeth.

7. Invisalign aligners and the dental treatment that is involved with it (Invisalign Aligner Treatment) is provided by dentists and/or orthodontists who supply the treatment to patients. 

8. SDC aligners and the treatment that is involved with it (SDC Aligner Treatment) is supplied by SDC to customers at the direction of, and under the supervision and control of, an Australian registered dentist or orthodontist (Affiliated Dentists) via a web-portal administered by SDC (SDC Platform). 

9. Invisalign, by its Amended CS, contends that SDC, in the course of promoting and marketing its SDC Aligner Treatment, made the following representations which it alleges are false, misleading or deceptive or are likely to mislead or deceive:

   (a)the total cost associated with treatment with SDC aligners is either $2,825 for upfront payment or $3,155 by instalments (Total Cost Representation);

   (b)the total cost associated with treatment with SDC aligners is less than $4 a day for the duration of treatment (or alternatively for the duration of a 90 day to 6-month treatment) (Less than $4 a Day Representation);

   (c)various representations set out at Amended CS [19] to the general effect that SDC Aligner Treatment is of comparable efficacy to treatment with traditional orthodontic treatment (being treatment from a dentist or orthodontist with an orthodontic appliance such as braces or Invisalign aligners) for all, or at least a majority of, patients (Comparable Treatment Representations);

   (d)various representations set out at Amened CS [20] to the effect that SDC Aligner Treatment is less expensive or ‘60% less’ or ‘up to 60% less’ expensive in all instances or alternatively for equivalent treatments obtained from an orthodontist or dentist such as braces or Invisalign (Price Comparison Representations);

   (e)SDC Aligner Treatment provides a comprehensive solution to all orthodontic issues or alternatively all non-severe issues (Comprehensive Solution Representation); and

   (f)SDC Aligner Treatment provides a comprehensive orthodontic solution to all orthodontic issues or alternatively all non-severe issues at significantly less cost than that of equivalent treatments with braces or Invisalign (Lower Cost Representation).

10. SDC AU, by its cross-claim, alleges that Invisalign made a number of representations about about the comfort, predictability and treatment time associated with its clear aligners (Invisalign aligners), that were false, misleading or deceptive or likely to mislead or deceive in contravention of ss 18 and 29 of the ACL.

11. SDC AU, by its cross-claim, also alleges that Invisalign has made certain representations about SDC aligners which are false, misleading or deceptive.  SDC AU alleges that these representations were made in an “advertorial” published by a number of news outlets entitled, “DIY teeth straightening kits – Should you try this at home?” (DIY article).  The DIY article was “created in partnership” with Invisalign.  SDC AU alleges that the DIY article, without mentioning SDC by name, makes various statements which it contends the ordinary and reasonable consumer would understand as referring to SDC aligners. 

12. SDC AU contends that the DIY article impliedly represents, inter alia, that SDC Aligner Treatment does not involve oversight by a dentist.  SDC AU contends that the representations are false, misleading or deceptive as SDC Aligner Treatment is supplied by SDC to customers at the direction, and under the supervision and control of, Affiliated Dentists using the SDC Platform.

13. For the sake of completeness, these reasons for judgment will refer to “consumers”, “customers” and “patients”, however each of these groups are used interchangeably and refer to the same group.

    RULINGS ON AMENDED CONCISE STATEMENT AND EVIDENCE

14. Before turning to the evidence, I will deal with certain outstanding issues which remain from the trial and which were articulated in the parties’ joint note to the Court which my chambers received on 7 December 2022.

15. These outstanding issues are:

    (a)Invisalign’s Amended CS;

    (b)Schedule 1 to Invisalign’s closing written submissions, including the affidavit evidence of Ms Jaimie Maree Wolbers as well as the material in annexure JMW-4 (exhibits 73 and 74); and

    (c)the evidence of Mr Cristofaro.

    Invisalign’s Amended Concise Statement

16. Invisalign, in its closing written submissions, attached an Amended CS in which it sought to add the words “60% less, or further or alternatively” to the existing Price Comparison Representations allegations pleaded in sub-paragraphs 20(c) and (d), which Invisalign submitted reflected the case, as opened (T60.16-30), and ultimately run, by Invisalign. 

17. SDC opposed the amendment to the CS on the basis that it substantially amended the case as pleaded under the Price Comparison Representations and would require SDC to adduce further and better pricing survey evidence.  SDC also opposed the amendment on the basis that there has been no explanation for the delay in seeking to amend the CS until closing submissions were filed.

18. The Court’s power to grant leave to amend is broad and has the remedial objective of ensuring that any defect in the pleading is cured and that the real questions that are the subject of the controversy are properly agitated: Caason Investments Pty Ltd v Cao [2015] FCAFC 94; 236 FCR 322 (Caason) at [20] (Gilmour and Foster JJ) and AON Risk Services Australia Ltd v Australian National University [2009] HCA 27; 239 CLR 175 at [14]. The power to grant leave to amend must be exercised in a “way that best promotes the Court’s overarching purpose to facilitate the just resolution of disputes according to law as quickly, inexpensively and efficiently as possible”: Caason at [19].

1. Leave to amend should generally be granted unless the proposed amendment is futile, including, for example, because the issue sought to be raised by the amendment has no reasonable prospect of success, or will be liable to be struck out as not raising a reasonable cause of action, or where the amendment would cause substantial prejudice or injustice to the opposing party in a way that cannot be compensated by an award of costs: Caason at [21] and KTC v David [2022] FCAFC 60 at [110]-[111] (Wigney, Anastassiou and Jackson JJ).

2. I am satisfied that the amendment to the CS is minor in nature and reflects the manner in which Invisalign ran its case, as such the amendment will be allowed. 

3. I am also satisfied that granting the amendment will not cause any prejudice or injustice to SDC and that it facilitates the just resolution of the disputes as quickly, inexpensively and efficiently as possible.

   Schedule 1 to Invisalign’s Closing Written Submissions

4. Invisalign’s closing submissions include a Schedule 1, entitled, “Promotional material relied upon by the Applicant”.  This Schedule 1 sets out, in table form, the promotional material exhibited to the affidavit of Jaimie Maree Wolbers sworn 4 April 2022 and annexure JMW-4, being a USB containing digital promotional material of SDC.  On day eight of the trial, on 19 October 2022, I provisionally admitted the affidavit of Jaimie Maree Wolbers sworn 4 April 2022 and annexure JMW-4 and marked it exhibit 73, subject to an objection by SDC: T658.20-660.05. 

5. Invisalign seeks to rely upon the promotional material identified in Schedule 1 to its written submissions in support of its claim.  As stated above in these reasons at [1], this promotional material is annexed to these reasons for judgment at Annexure C (Annexure C or Schedule 1). 

6. Invisalign accepts that the promotional material itemised in Annexure C contains material which goes beyond that identified in Annexure A to the Amended CS. 

7. SDC objects to the admission into evidence of certain material identified in Annexure C, which was shaded in green in the version of Annexure C which was annexed to SDC’s closing written submissions.  The material that was shaded in green is now redacted in the Annexure C to these reasons for judgment.  The basis of SDC’s objection to this material that was shaded in green was that it goes well beyond Invisalign’s pleaded case as identified in the Amended CS and its Annexure A.

8. The promotional material falls into two categories. 

9. First, material that contains the same, or substantially the same, statements as those in Annexure A.  These statements do not fall outside Invisalign’s pleaded case.  Second, promotional material that contains other unpleaded statements which, in SDC’s submission, falls outside Invisalign’s pleaded case. 

10. This second category is the promotional material that was shaded in green in the version of Schedule 1 which was annexed to SDC’s written closing submissions. 

11. SDC submits that Invisalign should not be permitted, at such a late stage of the proceeding, to tender and rely upon this additional promotional material.  That is so, in SDC’s submission, for two reasons. 

12. First, Invisalign’s closing submissions failed to squarely assert which of the many statements are said to convey the particular representations alleged.  SDC also submits that it is not apparent what Invisalign was referring to in column VII of Schedule 1 entitled “Specific to Price Comparison Representation”.

13. Second, SDC submits that Invisalign has provided no explanation for the delay in identifying the new statements contained in Schedule 1 which were highlighted in green.  SDC submits that with the exception of a relatively confined number of Facebook and Instagram advertisements that were produced during discovery and made available to Invisalign on 17 September 2022, the remainder of the promotional material referred to in Schedule 1 is taken from Ms Wolbers’ affidavit sworn 4 April 2022, annexure JMW-4 and the affidavit of Ms Niki Brown affirmed 1 July 2022. 

14. SDC submits that Invisalign has been on notice of this additional promotional material for an extended period of time and has not sought to amend its claim.  SDC submits that Invisalign is seeking to amend the Amended CS and its Annexure A by replacing it with Schedule 1, without any explanation as to why this was not done earlier and prior to the commencement of the hearing.

15. SDC submits that to permit Invisalign to tender the promotional material which is exhibit JMW-4 to Ms Wolbers’ affidavit sworn on 4 April 2022 for the first time in closing submissions is procedurally irregular and unfair.  SDC submits that the new promotional material has no probative value in circumstances where it does not reflect the pleaded statements in Annexure A to the Amended CS.

16. Invisalign submits that SDC has been on notice since it filed and served Ms Wolbers’ affidavit sworn 4 April 2022 and that Invisalign confirmed, by letter dated 28 June 2022, that it intended to rely upon all of the material in Ms Wolbers’ affidavit as well as relevant promotional material that came to light during the course of the proceeding. 

17. Invisalign submits that paragraph 15 of the Amended CS expressly stated that Annexure A to the Amended CS was a “sample” of the material ultimately to be relied upon and that Invisalign intended to rely on the entirety of the material in Ms Wolbers’ affidavit sworn on 4 April 2022 and any other relevant promotional material that came to light through discovery.

18. Invisalign contends that a concise statement is not a pleading and that as a consequence it is not required to expose issues in dispute to the same level of detail as in a pleading: Allianz Australia Insurance Ltd v Delor Vue Apartments CTS 39788 [2021] FCAFC 121; 396 ALR 27 per McKerracher and Colvin JJ at [140]-[150].

19. I will not admit into evidence those portions of Schedule 1 which were highlighted in green by SDC, and which are now redacted in Annexure C to these reasons.  The additional promotional material goes beyond the scope of the Amended CS and Annexure A 

20. Whilst an applicant may not be limited to matters strictly referred to in a concise statement, a respondent is entitled to fair disclosure of the case it is required to meet.

21. In my view, it is unfair for Invisalign, in its closing submissions, to seek to rely upon additional promotional material and to expand the scope of the evidence in circumstances where Invisalign has refused to provide particulars identifying the statements upon which it relies in the additional promotional material.  This is particularly the case in circumstances where on 28 June 2022, SDC’s instructing solicitors wrote to Invisalign’s solicitors seeking to understand the relevance of the additional promotional material and how Invisalign put its case.  At no point prior to closing submissions has Invisalign provided notice to SDC of the new statements contained in Schedule 1 upon which it now seeks to rely. 

22. Invisalign has also failed to identify, in its closing submissions, which of the many statements are said to convey the representations alleged. 

23. In those circumstances, in my view, it is unfair and prejudicial to SDC to admit into evidence the promotional material shaded in green which contain statements beyond those identified in the Amended CS and Annexure A.

24. It is also not apparent what Invisalign is referring to by column VIII entitled “Specific to price comparison representation”.  The material in this column will also be ruled inadmissible.

    Rulings on objections to the evidence of Mr David Cristofaro

25. Mr Cristofaro tendered three affidavits into evidence:

    (a)the affidavit of Mr Cristofaro dated 30 June 2022 (first Cristofaro Affidavit), marked exhibit 45;

    (b)the affidavit of Mr Cristofaro dated 26 September 2022 (second Cristofaro Affidavit), marked exhibit 46; and

    (c)the affidavit of Mr Cristofaro dated 13 October 2022 (third Cristofaro Affidavit), marked exhibit 47,

    (collectively, the Cristofaro Affidavits).

26. Mr Cristofaro’s evidence is relevant to the pricing claims made by Invisalign in the Amended CS, in particular, the Price Comparison Representations at Amended CS [20].

27. Invisalign objects to each of the three Cristofaro affidavits on the basis that the evidence given by Mr Cristofaro does not comply with s 79 of the Evidence Act 1995 (Cth) (EvidenceAct) and on the basis that aspects of his evidence is hearsay, conclusory and should be excluded pursuant to s 135 of the EvidenceAct.

28. SDC filed written submissions on 11 October 2022 in support of the admission into evidence of the first and second Cristofaro Affidavits.  Invisalign on 13 October 2022, filed written submissions objecting to the admission into evidence of the first and second Cristofaro Affidavits.  On 13 and 14 October 2022, I heard oral argument from the parties as to the objections to Mr Cristofaro's evidence as contained in the first and second Cristofaro Affidavits together with the third Cristofaro Affidavit.

29. On 14 October 2022, I ruled that the first and second Cristofaro Affidavits be admitted into evidence (T407.8-16).  At that time I informed counsel that I will publish my reasons for making that ruling in due course.  On Monday, 17 October 2022, I heard brief oral argument from counsel for Invisalign seeking to object to admissibility of the third Cristofaro Affidavit on the same basis as the previous two affidavits.  I informed counsel that the third Cristofaro Affidavit will be admitted into evidence, and that I will also publish my reasons for making that ruling in due course.

30. I now provide my reasons for the rulings made in respect of the Cristofaro Affidavits.

31. Mr Cristofaro is the principal of Actionable Research, a market research firm that he founded in 2002 in the USA that has clients including Johnson & Johnson, Pfizer, Roche and Invisalign’s parent company, Align Technologies, Inc. 

32. Actionable Research specialises in providing primary research for participants in the oral care industry, including all facets of oral health care delivery.  Actionable Research has conducted over 140 research projects involving dentists and orthodontists in numerous jurisdictions around the world, including Australia.  Mr Cristofaro has personally been involved in the design of the research, the sampling for the surveys, and the analysis of the data. 

33. Mr Cristofaro has written the survey and interview guide for approximately 70 percent of the studies conducted by Actionable Research.  He also regularly moderates market research focus groups and conducts one-on-one interviews with dentists and orthodontists in order to inform his understanding of the dental and orthodontic industry and so as to appropriately design survey questions.

34. SDC submits that Mr Cristofaro gives evidence of fact about a market research survey he conducted (Actionable Study) and the responses given to the Study.  SDC submits that Actionable Research was retained by SDC prior to the commencement of these proceedings in May 2021, to conduct market research into the prices charged for professional teeth straightening by dentists and orthodontists using braces and clear aligner treatment in Australia.  In order to conduct this research, Mr Cristofaro developed a questionnaire (Questionnaire) and oversaw a team at Actionable Research that conducted the Study.

35. The first Cristofaro Affidavit sets out the relevant methodology and results of the Actionable Study, including:

    (a)the study participants and sample size: [15]-[17], [22];

    (b)the screening criteria used when selecting participants for the study: [18]-[21];

    (c)the demographics of the study participants, including their geographic location, their years of experience, the types of dental procedures they performed and the number of case starts per year in their practice: [24]-[34]; and

    (d)the results of the Actionable Study in relation to pricing habits for braces and clear aligners: [35]-[51].

36. The first Cristofaro Affidavit annexes the raw data containing the responses obtained to the Questionnaire (exhibit DDC-2) (Raw Data), which is a 300 page document.  The affidavit also annexes:

    (a)the questions asked of dentists and orthodontists (exhibit DDC-1);

    (b)an Excel spreadsheet which calculates whether the average price reported in the Survey correlates to 60% less than Invisalign and braces (Calculation Spreadsheet) (exhibit DDC-3); and

    (c)two reports created during the course of preparing Mr Cristofaro's evidence which describe the results of the Actionable Study in respect of braces (Braces Report) (exhibit DDC-4) and Invisalign aligners (Invisalign Report) (exhibit DDC-5).

37. Invisalign has been provided with an electronic version of the Raw Data in response to a request made for it.

38. SDC submits that in respect of the First Cristofaro Affidavit, Mr Cristofaro provides a factual account of the processes he followed to conduct the Study and analyse and record its results, as well as the results of the Actionable Study.

39. SDC submits that the Second Cristofaro Affidavit was filed in reply to Invisalign's evidence (specifically the affidavit of Mr MacLean which calls into question the methodology of the Actionable Study) and further exposes Mr Cristofaro’s methodology in conducting the Actionable Study.  In particular, it addresses:

    (a)the selection of participants for the Actionable Study (Study Participants), including how Actionable Research has developed its database of dentists and orthodontists in Australia and its practices in conducting market research: [8]-[26];

    (b)testing of the results of the Actionable Study to account for geographic spread of dentists and orthodontists in Australia, to respond to criticisms of Mr MacLean: [27]-[32];

    (c)description of how Mr Cristofaro calculated the sample size of the Actionable Study: [33]-[43];

    (d)the financial contribution offered for participation in the Actionable Study: [44];

    (e)the nature of the questions asked in the Questionnaire, including the lack of pilot study: [45]-[50]; and

    (f)whether it was appropriate to “trim” the results of the Actionable Study to remove outliers: [51]-[52].

40. Invisalign objects to parts of Mr Cristofaro’s evidence on the basis that it is hearsay.

41. SDC submits that some paragraphs to which the hearsay objection is advanced are not hearsay.  These are:

    (a)[11]-[12] of the first Cristofaro Affidavit contain evidence of fact about the circumstances in which Actionable Research was retained by SDC and the instructions provided;

    (b)[15]-[16] of the first Cristofaro Affidavit again contain evidence of fact, this time about how Actionable Research identified potential Study Participants and invited them to participate in the Actionable Study;

    (c)[9]-[10] of the second Cristofaro Affidavit is factual evidence describing how Actionable Research developed its database of dentists and orthodontists in Australia;

    (d)[12] of the second Cristofaro Affidavit is factual evidence about how dentists were invited to participate in the Actionable Study; and

    (e)[20]-[26] of the second Affidavit is factual evidence about the Study Participants and their demographics, as well as some opinions offered about the sufficiency of the sample.

42. SDC submits that there are no prior representations contained in the above paragraphs. 

43. Invisalign submits that the results of the Actionable Study that are recorded in [2] and [26]-[33] are hearsay and inadmissible.  SDC accepts that insofar as Mr Cristofaro reports the answers given by dentists and orthodontists to the Questionnaire, this evidence is hearsay.  However, SDC submits that the evidence is admissible as it falls within one of the exceptions to the hearsay rule.

44. SDC relies upon s 69 of the EvidenceAct being the business records exception. SDC submits that the Raw Data are records belonging to or kept by Actionable Research in the course of completing the Actionable Study. The Actionable Study was conducted for the purpose of its business. The previous representations, being the responses from the participating dentists, were kept for the purpose of Actionable Research conducting the Actionable Study. In SDC’s submission, the Raw Data is a business record to which s 69 of the EvidenceAct applies.

45. SDC further submits that s 69(2) of the EvidenceAct provides that the hearsay rule does not apply to the document if the representation was made:

    (a)by a person who had or might reasonably be supposed to have had personal knowledge of the asserted fact; or

    (b)on the basis of information directly or indirectly supplied by a person who had or might reasonably be supposed to have had personal knowledge of the asserted fact. 

46. Here, SDC submits that the Study Participants were dentists and orthodontists in Australia. 

47. SDC submits that the Study Participants responded to questions about pricing for particular treatments at their own practices.  As such, SDC submits that the representations were made on the basis of information directly supplied by a person who had or might reasonably be supposed to have had personal knowledge of the asserted fact.

48. Accordingly, SDC submits that the answers to the Actionable Study recorded in the first Cristofaro Affidavit, including the Raw Data, are business records of Actionable Research and admissible pursuant to s 69 of the EvidenceAct.

49. SDC further submits that two further exceptions to the hearsay rule apply. First, s 64(2) of the EvidenceAct provides an exception to the hearsay rule in civil proceedings where the maker is available, where it would cause undue expense or undue delay, or would not be reasonably practicable, to call the person who made the representation to give evidence.  Here, SDC submits that the makers of the representations would be the 73 individual dentists and orthodontists who responded to the survey.  SDC submits that to call that evidence first hand would require affidavits from each of those dentists and orthodontists and would cause undue expense, delay and would not be reasonably practicable.

50. Secondly, s 66A of the EvidenceAct contains an exception for contemporaneous statements about a person's knowledge. SDC submits that the Raw Data records contemporaneous statements about the Study Participants’ knowledge about their experience, practices and pricing, given at a time prior to the proceedings brought by Invisalign against SDC. 

51. Thirdly, SDC submits that insofar as the Raw Data is admissible, so too are Mr Cristofaro’s explanations of the results contained in his affidavit.  Mr Cristofaro’s evidence simply summarises the evidence contained in the Raw Data, which spans some 300 pages.

52. SDC submits that s 29(4) of the EvidenceAct provides that evidence may be adduced as explanatory material that aids comprehension of other evidence.

53. SDC submits that in the first Cristofaro Affidavit, Mr Cristofaro simply explains what is shown by the Raw Data in respect of particular categories of answers.

54. Fourthly, SDC submits that in relation to [36]-[50] of the second Cristofaro Affidavit, the evidence contained in these paragraphs relates to Mr Cristofaro's use of an online calculator to calculate an appropriate sample size for the Actionable Study.

55. SDC submits that the evidence in [36]-[50] of the second Cristofaro Affidavit, falls into two categories.  First, [36] is evidence of the witness' direct knowledge of the formula used on the UBC Power Calculator website.  Paragraphs [37] to [38] provide an explanation of the terms used in that formula and in SDC's submission, are not hearsay.

56. Second, [39] describes the process that Mr Cristofaro followed when using the UBC Power Calculator.  SDC submits that this is not hearsay because it provides direct evidence of his processes. Similarly, SDC submits that [40] again provides direct evidence of the result generated by the calculator.

1. In relation to [40], SDC submits that it falls within s 146 of the EvidenceAct. That section applies where a document is produced by a device or process and is tendered by a party who asserts that, in producing the document or thing, the device or process has produced a particular outcome. If it is reasonably open to find that the device or process is one that, or is of a kind that, if properly used, ordinarily produces that outcome, it is presumed (unless evidence sufficient to raise doubt about the presumption is adduced) that, in producing the document or thing on the occasion in question, the device or process produced that outcome. SDC submits Mr Cristofaro that explained the information he input into the calculator (at [39]) and produced a screenshot of the results generated by the calculator (at [40]). This, in SDC’s submission, is sufficient to meet the presumption in s 146 that the calculator produced the results in that paragraph.

2. Invisalign also objects to the first Cristofaro Affidavit on the basis that it does not comply with the Court’s Survey Evidence Practice Note (GPN-SURV) (Survey Evidence Practice Note).  SDC submits that the Survey Evidence Practice Note is directed to the design of surveys conducted specifically for the litigation in which it is proposed to be used to address a particular issue in the proceedings (most commonly involving intellectual property disputes): Australian Competition and Consumer Commission v Australian Institute of Professional Education Pty Ltd (in liq) (No 2) [2018] FCA 1459 at [32].

3. SDC submits that the Actionable Study was conducted well before the commencement of proceedings and therefore cannot be assessed against the standards in the Survey Evidence Practice Note. Insofar as Invisalign objects to any opinion expressed by Mr Cristofaro about the Actionable Study and its results on the basis of his expertise, SDC submits that this objection is answered by Mr Cristofaro’s experience in conducting studies of this kind and in this industry. SDC submits that Mr Cristofaro has conducted market research surveys for around 20 years, and has been involved in around 100 surveys of dentists and orthodontists. SDC submits that he therefore has "specialised knowledge" based on his experience to bring him within s 79 of the Evidence Act and is qualified to offer his opinion about the adequacy of the Actionable Study.

4. Invisalign also objects to Mr Cristofaro’s evidence on the basis that he has not adopted the Expert Witness Code of Conduct.

5. SDC submits that the Expert Witness Code of Conduct and the Survey Evidence Practice Note have no application in this case where a witness, here Mr Cristofaro, has prepared a report prior to the commencement of litigation at a time when he or she was not retained to provide an independent opinion to the Court. SDC submits that Mr Cristofaro and Actionable Research were retained prior to litigation commencing for the purpose of carrying out their survey and were therefore not "retained" to give opinion evidence in the proceeding. In any event, SDC submits that non-compliance with the Expert Witness Code of Conduct does not mandate exclusion of the evidence. Rather, the issue is whether non-compliance gives rise to a reason to exclude the evidence pursuant to s 135 of the EvidenceAct.

6. Invisalign also seeks to exclude Mr Cristofaro’s evidence on the basis that its probative value is substantially outweighed by the danger that the evidence might (a) be unfairly prejudicial to a party, (b) be misleading or confusing, or (c) cause or result in undue waste of time.

7. Mr Cristofaro’s affidavits purport to give evidence of an online survey undertaken by Actionable Research pertaining to various matters including the price of clear aligner therapy and braces.  In his affidavits, Mr Cristofaro refers to this as the "engaged study".  Invisalign’s overarching objection to Mr Cristofaro’s affidavits is threefold:

   (a)the Raw Data and the reports, opinions and conclusions that are derived from the Raw Data are relied on for a hearsay purpose and are inadmissible under s 59 of the EvidenceAct;

   (b)much of this material also amounts to opinion evidence which should be excluded under s 76 of the EvidenceAct, given that the conditions of expert opinion evidence under s 79 of the Act are not met, and in any event, SDC has expressly said that Mr Cristofaro is not an expert witness; and

   (c)while it seems that there may have been earlier versions of some of these materials, the versions of the Actionable Research reports and the Calculations included in the first Cristofaro Affidavit were prepared for the purpose of this proceeding. For this and other reasons, the evidence should be excluded under s 135 of the EvidenceAct.

   Section 69 Evidence Act – Business Records

8. Invisalign submits that the authorities consistently distinguish between the "business records" and the "products" of a business. Invisalign's submission is that only the former fall within s 69 of the EvidenceAct.  Invisalign submits that the Raw Data and all the records and conclusions derived from that data, are the products of Actionable Researcher's business as a market research firm. 

9. Invisalign relies upon the decisions of Roach v Page (No 15) [2013] NSWSC 939 per Sperling J and Australian Competition and Consumer Commission v Air New Zealand(No 1) [2012] FCA 1355; 207 FCR 448 for the proposition that published output of a business in literary form such as books, magazines and newspapers are not "business records", but rather, are "products of the business", falling outside the business records exception in s 69(1) of the EvidenceAct.

10. Invisalign also relies upon the decision of Middleton J in Hanson Beverage Co v Bickfords (Australia) Pty Ltd [2008] FCA 406; 75 IPR 505 at [110], [114], [131]-[133] where his Honour determined that television rating data (which Invisalign submits is analogous material to the Raw Data in the present case) did not fall within the business records exception to s 69(2) of the EvidenceAct and were not admitted into evidence.  Middleton J concluded that the ratings data were the "product of a business" and not a business record.

    Consideration of objections to Mr Cristofaro’s evidence

11. The proposition that "output" or "product" of a business falls outside the business records exception in s 69 of the EvidenceAct has been doubted, and rejected, in more recent authorities on the basis that s 69(1) includes records "kept … for the purposes of a business": Southern Cross Airports v Chief Commissioner of State Revenue [2011] NSWSC 347 (Southern Cross) per Gzelle J at 41-44 and Rodney Jane Racing Pty Ltd v Monster Energy Company [2019] FCA 923; 142 IPR 275 (Rodney Jane) per O’Bryan J at 175-176.

12. Similarly in Charan v Nationwide News Pty Ltd [2018] VSC 3 at [463], Forrest J stated:

    …the distinction between 'product' and 'records' is problematic. It does not appear in the text of s 69(1). The language used in the provision is broad and appears to encompass any documents kept by a person, body or organisation 'in the course of, or for the purposes of' a business. To exclude documents that are part of the records of an organisation, however generated and for whatever purpose under this provision (as opposed to a subsequent discretionary exclusion under s 135) involves, I think, an artificial distinction not covered by the wording of the section.

    (Emphasis added)

13. In Dr August Wolff GmbH & Co. KG Arzneimittel v Coombe International Ltd [2020] FCA; 149 IPR 1 39 at [112]-[134] (Dr Wolff), the relevant question before Stewart J was whether various survey reports were admissible as an exception to the hearsay rule: at [112]-[134].

14. The surveys were commissioned and obtained by the parties to the proceedings, prior to the commencement of proceedings, for the purpose of the conduct of their businesses.  In relation to the reports, Stewart J noted at [122]:

    Material common elements of all the reports are the following.  First, they were commissioned by the relevant owner of the brand from specialist professional survey companies.  Secondly, they record respondents' responses or answers to survey questions, or other feedback from the respondents.  Thirdly, they aggregate particular responses and produce, or calculate, some statistical outcomes.  Fourthly, they were commissioned in the course of the business of the owner of the brand for the purpose of the conduct of its business (i.e. in order to be able to rely on the information in the reports in taking business decisions), and they were produced by the survey companies in the course of their business.  Fifthly, they were kept or stored as part of the records or archives of the commissioning company and (presumably) the survey company.

15. Stewart J did not accept that the survey reports were the “products of the business”. Rather, “guided by the provisions of s 69”, his Honour held that “the survey reports form part of the records belonging to or kept by [Combe or Combe Asia-Pacific] in the course of, or for the purposes of, a business” (at [131]-[132]). Stewart J admitted the survey reports and concluded in respect of whether the reports formed part of the records belonging to the business:

    Clearly they do.  They were commissioned for the purpose of the business of the owner of the brand in each case, with the intention that they would be relied on in various ways including in devising advertising campaigns and, possibly, in developing and marketing products.  Whilst they do not record the activities of the business, they are records produced for the purpose of those activities.  They were intended to be relied upon by the business, and there is no reason to suppose that the hearsay statements recorded in the report are other than accurate.

    (Emphasis added)

16. Likewise in the present case, the survey was commissioned by SDC prior to the commencement of the proceedings, for the purpose of SDC's business and was intended to be relied on by SDC in its business activities: first Cristofaro Affidavit at [11]-[12].

17. The survey was carried by Actionable Research and the survey data collected in the ordinary course of Actionable Research business: DrWolff at [122]. There is no reason to suppose that the hearsay statements contained in the data are other than accurate responses. I am of the view that the survey data falls within the clear and unequivocal meaning of the words in s 69(1) of the EvidenceAct and is admissible as an exception to the hearsay rule.

18. Each of the first, second and third Cristofaro Affidavits will be admitted into evidence.

    THE EVIDENCE

19. A list of the affidavits tendered by the parties are in Annexure A to these reasons for judgment. 

    INVISALIGN’S EVIDENCE

20. Invisalign tendered affidavit evidence from a number of witnesses, some of whom were not required to attend for cross-examination.  That evidence may be summarised as follows.

    Ms Karen McGoldrick

    Evidence in chief

21. Ms Karen McGoldrick is the Managing Director of Invisalign in Australia and New Zealand. 

22. Ms McGoldrick affirmed one affidavit dated 4 April 2022, which was tendered in evidence and marked exhibit 29. 

23. Ms McGoldrick deposed to her significant experience as a company director, having spent 28 years working in various directorship positions at Unilever, immediately prior to commencing as the Managing Director at Invisalign in August 2015.  

24. In her current role, Ms McGoldrick is responsible for leading, managing and directing Invisalign’s business in Australia and New Zealand. 

25. Ms McGoldrick gave evidence about the background to Invisalign, the Invisalign system and Invisalign treatment in Australia.  Ms McGoldrick’s evidence on these topics can be summarised as follows.

26. Invisalign Australia is the Australian subsidiary of Align Technology, Inc. (Align Technology), a global medical device company whose corporate headquarters is located in the United States of America (USA).

27. Since about December 2001, clear dental aligners, under the Invisalign brand name and trade mark, forming an orthodontic appliance treatment system (the Invisalign system) have been available in Australia. 

28. At the time of the lnvisalign system’s launch in Australia in 2001, Align Technology already had eight international sales offices in the United States, Europe and Latin America, and had over 30,000 patients that were receiving treatment using the Invisalign system.  Invisalign also has around 10,000 doctors trained and certified to prescribe the Invisalign system.

    The Invisalign system

29. The Invisalign system was originally designed and created by Align Technology in 1997, with a vision to design an orthodontic treatment system that could be offered by doctors to their patients as an aesthetic and comfortable alternative to traditional fixed braces.  No metal or ceramic brackets nor wires are used as part of the Invisalign system.

30. Since about 2011, following the acquisition of Cadent Holdings, Inc., Align Technology has also been the supplier of the iTero intraoral scanner (iTero scanner), which doctors can use to take 3D scans of a patient’s teeth and gums.

31. The current version of the Invisalign system features:

    (a)the use of a series of clear removable aligners, worn over a patient’s teeth, that gently move teeth to a desired final position in order to correct or treat malocclusion;

    (b)the clear aligners are made with “SmartTrack” material, a proprietary and multilayer orthodontic aligner material;

    (c)“attachments” which are nearly always prescribed by the treating doctor as part of a patient's treatment plan, depending on the patient's individual circumstances. Attachments are small pieces of enamel-coloured composite which the doctor fixes onto the patient's teeth to help the aligner grip the teeth providing additional force and greater control over the movement of teeth than clear aligners alone. The combination of attachments in a treatment plan are custom designed for the individual patient's treatment; and

    (d)depending on the patient’s individual circumstances, the treating doctor may also use orthodontic elastics with the lnvisalign system.

    Registration of the Invisalign system in Australia

32. Invisalign Australia is the sponsor, for the purposes of registration with the Therapeutic Goods Administration (TGA), of the Invisalign system in Australia.

33. In 2018, in anticipation of the likely regulatory developments in Australia, Invisalign Australia took steps to register the Invisalign system as a class I medical device with TGA.

34. Invisalign Australia holds the following registrations under the Australian Register of Therapeutic Goods (ARTG) for the Invisalign system:

    Invisalign treatment options

35. Since 2018, Invisalign has offered a number of different treatment options and packages to trained doctors to offer to Invisalign customers.  These were:

    (a)Invisalign Clear Aligners Express package;

    (b)Invisalign Clear Aligners Lite package;

    (c)Invisalign Clear Aligners Moderate package;

    (d)Invisalign Clear Aligners Comprehensive package;

    (e)Invisalign First Comprehensive package;

    (f)Invisalign System Comprehensive Phase 2 package; and

    (g)Invisalign Go,

    (collectively, the Invisalign Treatment Packages).

36. Ms McGoldrick, in her affidavit, described each of the Invisalign Treatment Packages and the type of customers that would fit within a particular package.  In short compass, each of the Invisalign Treatment Packages differ based on the idiosyncratic requirements of the level of aesthetic correction required by the customer (such as the amount of tooth movement required, the level of teeth spacing, crowding, malocclusion, as well as the age of the patient).  

    Training of doctors

37. Invisalign Australia only supplies the Invisalign Treatment Packages to eligible doctors who have received training in the use of the Invisalign system.

38. Since 2001, Invisalign Australia has continued to offer training courses in Australia, which is offered by the Invisalign Australia team as well as other independent practitioners.  There are three training courses that Invisalign Australia offers:

    (a)the Invisalign Fundamentals training course, which is targeted at dentists to use the Invisalign system and is best designed for dentists and orthodontists that have existing teeth straightening experience;

    (b)the Invisalign Go Fundamentals training course, which is targeted at general dentists that have little to no teeth straightening experience; and

    (c)the Invisalign Ignite training course, which is targeted at dentists that have previous experience using Invisalign Go, but wish to expand their treatment repertoire to include the full suite of Invisalign Treatment Packages,

    (each a Training Course, collectively, the Training Courses).

39. Ms McGoldrick, in her affidavit, described each of the Training Courses. 

    Marketing and promotion of the Invisalign system

40. Since the launch of the Invisalign system in Australia in 2001, Invisalign Australia has promoted its brand and the Invisalign system in Australia through consumer marketing and marketing which specifically targets doctors.

41. With respect to consumer marketing, Invisalign Australia has, since at least 2016, advertised and promoted its products in Australia through a number of channels, including the following:

    (a)the Invisalign Australia website located at media;

    (f)digital channels;

    (g)out-of-home advertising commonly by way of digital panels at retail;

    (h)shopping centres and gyms; and

    (i)interactive customer experiences offered through the Invisalign Centre and popups in Westfield shopping centres.

42. Invisalign also sponsors events in Australia such as the Mercedes Benz Fashion Week in 2019.  Ms McGoldrick deposed that advertising its brand at events such as Mercedes Benz Fashion Week offers increased media exposure and further promotes awareness of its products.

    Cross-examination of Ms McGoldrick

43. Ms McGoldrick gave evidence that in order to provide Invisalign Aligner Treatment in Australia and indeed, to complete the Training Courses, it was a requirement that the course attendee was a dentist or an orthodontist. 

44. Ms McGoldrick was asked about the Invisalign Go Fundamentals training course.  Ms McGoldrick explained that the Invisalign Go Fundamentals training course is designed for dentists with little to no teeth straightening experience for simple teeth straightening cases, and involves a full day course.  Once the dentist has completed this course, they are able to provide the Invisalign Go treatment in Australia. 

45. Ms McGoldrick was asked about the Invisalign Fundamentals training course.  Ms McGoldrick explained that this course is for dentists (more particularly, those dentists that have some experience in teeth straightening and have confidence in orthodontic treatment planning) and is designed to enable the dentist to use the full suite of the Invisalign Treatment Packages in Australia, once they have completed the Training Course.

46. Ms McGoldrick explained that the ClinCheck software is the system by which Invisalign interacts with the dentists and orthodontists that have completed one of its Training Courses.  Once a dentist or orthodontist has completed a Training Course they are then an Invisalign provider (Invisalign provider). 

47. After a dentist has completed the Invisalign Fundamentals training course they are then able to access the ClinCheck software, and that dentist, now an Invisalign provider, is able to access and order the full range of Invisalign Treatment Packages from within the system.  Whereas a dentist that has completed the Invisalign Go Fundamentals training course is only able to order the Invisalign Go product through the ClinCheck system. 

48. The Invisalign provider is then able to submit information to Invisalign through the ClinCheck system under what is called a “prescription form”.  Then, based on the information that is provided within the prescription form, Invisalign, through its ClinCheck system, produces a 3D treatment plan with the help of certain Invisalign technicians (Invisalign technicians).  Ms McGoldrick explained that these Invisalign technicians are based in Costa Rica and do not have Australian dental or orthodontic qualifications. 

1. Ms McGoldrick gave evidence that Invisalign leaves the process of patient diagnosis entirely up to its Invisalign providers.  Ms McGoldrick explained that the ClinCheck software allows Invisalign providers to approve or modify the 3D treatment plan that is generated.  Any updates or modifications to these plans can be made by the Invisalign provider in minutes, or less.  This process can also be done live, such that the Invisalign provider can work with the Invisalign technician in real time to update or modify the 3D treatment plan at their direction.  Ms McGoldrick stated that Invisalign providers are encouraged to use the ClinCheck system in this way to speed up the turnaround time for customers. 

2. Ms McGoldrick outlined, in further detail, the process surrounding the use of the ClinCheck system.  Ms McGoldrick illustrated how, once an Invisalign provider has diagnosed a patient, they will then complete a treatment form and will enter the patient’s records into the system.  These treatment forms are then sent to the Invisalign technicians in Costa Rica who then create the 3D treatment plan for that patient.  The 3D treatment plan is then sent back to the Invisalign provider for their review to enable them to make sure that it is in line with the patient’s objectives for treatment.  Ms McGoldrick gave evidence that there is usually a series of modifications that the Invisalign provider will make and send back to the Invisalign technician.  Ms McGoldrick told the Court that, on average, an Invisalign provider will make three modifications to a patient’s treatment plan.  Ms McGoldrick was able to provide this average based on data that is stored within the ClinCheck system.  This process occurs until the Invisalign provider is satisfied with the treatment plan.

3. Ms McGoldrick was asked about the number of Invisalign providers in Australia.  This information is confidential in nature, however Ms McGoldrick provided a confidential note to the Court, marked MFI-2, which contained the breakdown of these figures. 

4. Ms McGoldrick was asked about Invisalign Virtual Care.  Ms McGoldrick was played part of a YouTube video entitled “My Invisalign App – patient instruction video” published 7 October 2020, and marked exhibit 33.  This YouTube video was annexure GB-126 to the affidavit of Greg Bodulovic affirmed on 10 October 2022.  Exhibit 33 is an instructional video which shows the viewer how to use Invisalign’s mobile app (My Invisalign App or Invisalign Virtual Care).  A screenshot of part of this video is extracted directly below. 

5. Ms McGoldrick gave evidence that Invisalign Virtual Care allows Invisalign providers to monitor the progress of their patients’ Invisalign Aligner Treatment virtually.  This is able to be done because Invisalign Virtual Care enables patients to take photos and videos of themselves and upload these photos directly to the My Invisalign App, which can be accessed by the Invisalign provider.  The Invisalign provider can then respond to the patient through the app and can also review the progress photos that they receive via the My Invisalign App. 

6. Ms McGoldrick was asked about the TGA process undertaken by Invisalign, with particular emphasis on the registration of its products that are registered on the ARTG.  Ms McGoldrick gave evidence about the two ARTG identifiers that are each registered as “Medical Device Class 1” on the ARTG.  Ms McGoldrick explained that the TGA changed their guidelines and in order to ensure that Invisalign complied with the TGA, Invisalign registered these products as medical devices on 23 November 2020.

7. Ms McGoldrick explained that the “sponsor” of these ARTG registrations was Invisalign Australia Pty Ltd, which means that this entity is the supplier of the product in Australia.  Ms McGoldrick gave evidence that these ARTG registered products are subject to certain conditions.  Ms McGoldrick, under cross-examination, stated that one of the conditions that has been imposed upon Invisalign is that it, as the sponsor, must report any adverse events which patients experience as a result of being treated with the Invisalign system to the TGA. 

8. Ms McGoldrick gave evidence about Invisalign’s consumer marketing.  Ms McGoldrick conceded that SDC’s brand is reasonably well-known in Australia and that, in her view, it has become reasonably well-known to Australian consumers that SDC offers a direct to consumer model.  Ms McGoldrick agreed that the price of SDC aligners has become reasonably well-known to Australian consumers. 

9. Ms McGoldrick was taken to the DIY article and was shown a sentence on the ultimate page of the article which reads:

   Invisalign wants to ensure Australians considering teeth straightening know the facts, what to ask and what they’re getting, so they created the Be Clear on the Facts.

10. The above text is hyperlinked, such that when one clicks on the words “Be Clear on the Facts”, they are taken to Invisalign’s website and, in particular, to its webpage entitled “Be Clear on the Facts”, which Ms McGoldrick told the Court she is familiar with. 

11. Ms McGoldrick identified that the DIY article would have been “driven” by Invisalign’s marketing team. 

12. Ms McGoldrick gave evidence about Invisalign’s review committee.  Ms McGoldrick explained that the review committee consists of a marketing representative, a legal representative and a clinical representative and they meet weekly to review material to ensure that it complies with all of these different areas before material gets published and before they take it to the consumer.  Ms McGoldrick stated that she was not involved in any of the committee’s meetings in respect of the DIY article.

13. I find Ms McGoldrick to be a truthful witness whose evidence I accept. 

    Dr Bradley Stanley

14. Dr Stanley swore one affidavit dated 6 May 2022, which was tendered in evidence and marked as exhibit 78. 

15. Dr Brad Stanley is an Australian registered dentist with more than 30 years of dental practice experience.  Dr Stanley gave evidence relating to the pricing of treatment using the Invisalign system. 

16. Dr Stanley deposed to the prices that he charges patients at his practice for the provision of Invisalign Aligner Treatment.  Dr Stanley outlined how these prices vary depending upon the complexity of a patient’s treatment plan and the number of clear aligners that are needed to achieve the programmed treatment outcomes.  The pricing structure adopted in Dr Stanley’s practice falls into four tiers, which are:

17. The price for each package includes the following products and services:

    (a)initial diagnostic assessment which includes an intraoral exam and diagnostic record taking (including radiographs, photographs and an intraoral scan);

    (b)treatment planning;

    (c)an appointment to place attachments and fit the aligners;

    (d)an in-person consultation approximately every 4 weeks to monitor the patient’s progress; and

    (e)fixed or removable retainers following completion of treatment.

18. Dr Stanley was not called for cross-examination. 

    Ms Jaimie Wolbers

19. Ms Jaimie Maree Wolbers is the solicitor employed by MinterEllison, the solicitors for Invisalign.  Ms Wolbers gave evidence relating to SDC marketing material she had obtained by taking internet and other web-based searches. 

20. Ms Wolbers swore two affidavits that were tendered in evidence.  The first was dated 4 April 2022 and marked exhibit 73.  The second was dated 5 August 2022 and marked exhibit 74.

21. Ms Wolbers’ affidavits detail searches which she and MinterEllison conducted.  These searches related to:

    (a)SDC company information;

    (b)SDC website information as well as SDC’s social media webpages;

    (c)SDC’s advertisements and advertorial content;

    (d)Google search engine results for various terms including “DIY teeth straightening” among other things;

    (e)advertorial content of other similar aligner brands;

    (f)Australian Competition and Consumer Commission (ACCC) media releases; and

    (g)the Orthodontics Australia webpage.

22. Ms Wolbers was not called for cross-examination. 

    Mr Jack Stanley

23. Mr Jack Laurence Stanley is a solicitor employed by MinterEllison, the solicitors for Invisalign. 

24. Mr Stanley affirmed one affidavit dated 5 August 2022, which was tendered in evidence and marked exhibit 77.  

25. Mr Stanley’s affidavit provided a response to the affidavit of Mr Greg Bodulovic dated 1 July 2022. 

26. Mr Stanley deposed to searches he made with respect to webpages that were referenced in Mr Bodulovic’s affidavit at [24] and [25] and shown at annexure GB-30.  These searches were produced in order to negate any inference that Mr Bodulovic might have made to suggest that patients of dentists and orthodontists who utilise “DentalMonitoring”, (which is a remote monitoring solution that enables dentists and orthodontists to view the progress made by their patients by allowing patients to scan their teeth and take intraoral images with DentalMonitoring’s proprietary ScanBox Pro Device.  The patient can then upload these images to the patient app for their dentist to view).  Mr Stanley provided copies of screenshots which were annexed to his affidavit.

27. Mr Stanley was not called for cross-examination. 

    Dr Vicki Vlaskalic

28. Dr Vicki Vlaskalic is a practising orthodontist who owns and operates her own practice and is also a clinical instructor in the Department of Orthodontics at the University of Melbourne.  Dr Vlaskalic is a Clinical Consultant to Invisalign.  Dr Vlaskalic gave expert evidence relating to orthodontic treatment in Australia, including the use of clear aligner therapy and evidence relating to the price of treatment. 

29. Dr Vlaskalic prepared two affidavits which were tendered in evidence.  Dr Vlaskalic’s first affidavit sworn 6 May 2022, was marked as exhibit 2; and her second affidavit sworn 6 August 2022, was marked as exhibit 3.  Dr Vlaskalic participated in an expert conference which produced a joint expert report dated 5 October 2022, which was tendered in evidence and marked exhibit 8 (Joint Expert Report).  Dr Vlaskalic also gave concurrent evidence with the other dental and orthodontic experts called to give evidence in the proceeding.

30. Dr Vlaskalic, in her affidavit evidence, provided an overview of:

    (a)the concept of malocclusion, and her understanding of the phrase “mild to moderate malocclusion”;

    (b)the basic biomechanics that are involved in moving teeth;

    (c)the objectives of orthodontic treatment as well as the diagnostic and treatment planning processes that are involved in orthodontic practice; and

    (d)clear aligner therapy in further detail, including the background to clear aligner therapy;

    (e)the “Consent and History”, the “Pricing Page”, the “Night time Clear Aligners” and the “Smile Assessment” pages of the SDC’s website.

31. Dr Vlaskalic also provided a response to certain matters raised and opinions expressed in affidavits of Dr Derek Mahony, Dr Hendrick Lai and Dr Jeffrey Sulitzer.

32. Dr Vlaskalic’s affidavit evidence ran 169 pages, including annexures.  Ultimately the issues between the experts were narrowly defined, which is exemplified by the Joint Expert Report and the evidence that was given in the expert conclave.  I deal with Dr Vlaskalic’s evidence in greater detail below. 

    Dr Eugene Chan

33. Dr Eugene Chan is a practising orthodontist who owns and operates his own orthodontic practice.  Dr Chan has been appointed by the Dental Board of Australia as an arbitration consultant regarding complaints or concerns raised relating to dental and orthodontic practitioners.  Dr Chan is also a clinical consultant to Invisalign.  Dr Chan provided expert evidence pertaining to orthodontic treatment in Australia, including the use of clear aligner therapy and evidence relating to the price of treatment.  Dr Chan prepared two affidavits which were tendered in evidence.  Dr Chan’s first affidavit sworn 6 May 2022, was tendered in evidence and marked as exhibit 1; and his second affidavit sworn 5 August 2022, was marked as exhibit 4.  Dr Chan also gave concurrent evidence with the other dental and orthodontic experts called to give evidence in the proceeding. 

34. Dr Chan, in his affidavit evidence, provided an overview of:

    (a)the orthodontic profession in Australia, including the educational and other requirements for registration as an orthodontist, and also the professional standards that orthodontists practicing in Australia are expected to meet;

    (b)general concepts relating to the underlying anatomy and biology that guide orthodontic treatment and practice;

    (c)malocclusion, its definition and meaning;

    (d)the biomechanical principles that guide tooth movement, as they apply to orthodontic treatments;

    (e)the type of orthodontic treatments available in Australia and commonly used in orthodontic practice;

    (f)the process of patient assessment and diagnosis in orthodontic treatment, including where clear aligners are used;

    (g)the factors that are considered in orthodontic treatment planning and implementation, including choice of orthodontic appliance, use of attachments in clear aligner therapy, and obtaining consent to treatment;

    (h)how the outcomes of orthodontic treatment are measured and evaluated;

    (i)how Dr Chan manages patients who present with requests for cosmetic-only treatment, (treatment that corrects the aesthetic aspects of their malocclusion without addressing co-existing functional problems);

    (j)how Dr Chan uses Invisalign clear aligners in his practice;

    (k)the cost of treatment using braces, Invisalign Aligner Treatment, or other clear aligners for treatment of a simple correction of overcrowding or spacing issues involving the front six upper and/or lower teeth; and

    (l)his awareness of SDC Aligner Treatment and how it is marketed.

35. Dr Chan also provided a response to certain matters raised and opinions expressed in affidavits of Dr Derek Mahony, Dr Hendrick Lai and Dr Jeffrey Sulitzer.

36. Dr Chan's affidavit evidence ran 270 pages, including annexures.  Ultimately the issues between the experts were narrowly defined, which is exemplified by the Joint Expert Report and the evidence that was given in the expert conclave.  I deal with Dr Chan’s evidence in greater detail below. 

    Mr Alan Scott MacLean

    Evidence in chief

37. Mr Alan Scott MacLean is a marketing research and data analyst and is the Principal and Director of Nulink Analytics Pty Ltd (Nulink Analytics).  Mr MacLean was retained by MinterEllison, the solicitors for Invisalign, to provide an expert opinion in relation to the market research Actionable Study undertaken by SDC’s marketing analytics expert, Mr David Cristofaro and his company, Actionable Research.

38. By way of brief background, Mr Cristofaro, conducted the Actionable Study that surveyed 73 Australian dentists and orthodontists about their pricing.  Mr Cristofaro, in the first Cristofaro Affidavit, identified the objectives for the Actionable Study.  These were:

    (a)to determine the average case numbers of a representative sample of general dentists and orthodontists in full-time practice in Australia;

    (b)to understand the Study Participants’ usage of aligner-based treatment products from different companies;

    (c)to determine the average price charged for aligner-based treatment and fixed appliances (namely braces) and the price charged most often (the mode price charged) as a function of treatment method, condition severity, and other relevant factors;

    (d)to determine the criteria used by dentists and orthodontists to determine pricing for treatment of their aligner-based and fixed appliance-based cases; and

    (e)to determine the difference between the amounts charged by dentists and orthodontists for aligner-based and fixed appliance-based cases and the amounts patients pay for these services.

39. Mr Cristofaro’s Actionable Study identified that the overall average fee charged for braces in treating mild to moderate malocclusion at the time of the data collection in July 2021 was $6,939 and the overall median fee was $7,100.  Mr Cristofaro identified that the overall average fee charged for treatment using Invisalign Aligner Treatment for mild to moderate malocclusion was $6,926 and the overall median fee was $7,000.  Mr Cristofaro found that the average and median prices were higher for severe malocclusion.  Mr Cristofaro also identified that the fees charged for treating mild to moderate malocclusion by braces ranged from $3,500 to $9,180, whereas Invisalign Aligner Treatment ranged from $4,500 to $9,500.

40. Mr MacLean affirmed one affidavit dated 30 August 2022, which was tendered in evidence and marked exhibit 58 (MacLean Affidavit).

41. Mr MacLean deposed to his experience in marketing research and data analytics.  Mr MacLean outlined how in order to design and implement any survey for the purpose of achieving the objectives identified above at, the following matters, at a minimum, are essential to achieve any kind of reliability in the interpretation of results:

    (a)the interviewed sample needs to be representative of the target population or able to be reweighted so as to represent the target population;

    (b)an appropriate sample size needs to be determined.  In this regard, the considerations elucidated by William G. Cochran in 'Sampling Techniques, 2^nd Edition' (1963, John Wiley & Sons Ltd) need to be followed, which includes the need to achieve a balance between the reliability in the results and controlling the costs of the work to be undertaken;

    (c)questions asked during the interview need to be unambiguously understood by respondents in order for them to frame their responses correctly, as detailed by Sudman, Bradburn, and Schwartz in ‘Thinking about answers – the Application of Cognitive Processes to Survey Methodology’ (1996, Jossey-Bass Publishers).  This could be achieved, for example, through both the pre-piloting and piloting of the survey instruments and procedures;

    (d)objectives of the project need to be sufficiently clear to allow the appropriate questions to be asked in the appropriate manner;

    (e)prior to analysis, results should always be cleaned to remove “speeders” (respondents who answer too quick to sensibly be responding to the survey questions), and “flatliners” – (respondents who show little or no variation across their answers to the questions (e.g. answering 5, 5, 5, 5 for all questions)); and

    (f)the assumptions underlying the statistical tests utilised in the analysis need to be sustainable.  For example, the “t-test” assumes at least approximate normality in the distribution of the target metrics within the population.

42. Mr MacLean provided evidence about the financial contribution that was offered as part of Mr Cristofaro’s survey.  Mr MacLean’s evidence was that he understood that the Study participants in Mr Cristofaro’s Actionable Study were offered a “small financial contribution” to complete the Questionnaire in order to “increase the response rate to the Actionable Study”.  Mr MacLean identified that he had not been told the amount of that financial contribution.  Mr MacLean’s evidence was that the level of financial contribution can be an important factor in determining whether the Study Participants have been influenced in their willingness to participate in the questionnaire.  This is because, in Mr MacLean’s view, if the financial contribution offered is well below a professional’s usual hourly rate, it may negatively affect a professional’s willingness to be interviewed or participate in a survey which can be an obstacle in obtaining the requisite number of respondents for the survey.  Further, for those who agree to participate, it may affect the time and care that the individual devotes to answering the survey.

43. In relation to the Questionnaire that was used in the survey that Mr Cristofaro sent out to the Study Participants, Mr MacLean provided the following comments:

    (a)it does not appear that Actionable Research conducted a pilot survey before proceeding with the questionnaire.  It is best practice to conduct a pilot first, or at least to run through the questions that one intends to ask with a handful of potential respondents;

    (b)you cannot in general assume that people understand the questions being asked in questionnaires.  Particularly in the absence of a pilot, and given Survey Participants are not being guided through the questionnaire;

    (c)the questions in the Questionnaire, relating to prices charged, use terms such as “the fee you charged most often”, “average fees”, “range of fees”, and “minimum and maximum price”.  It is unclear why the Study Participants were asked questions in relation to the fees they charge in all of these different ways.  In particular, it is unclear why Actionable Research has asked for the fee charged most often as well as the average fee charged.  A questionnaire designed to elicit information about prices charged, in order to prompt the most accurate responses, should include instead questions along the lines of: “of the fees you charged, what is the minimum, what is the maximum and what is the average?”.  In Mr Maclean’s experience, there would also be a risk of respondent fatigue at this stage of the Questionnaire.  Mr MacLean explained that respondent fatigue is a “well-documented phenomenon” that occurs when Study Participants become tired of the survey task and the quality of the responses they provide begins to deteriorate which can lead to unreliable results.  It occurs when Study Participants’ attention and motivation drop toward later sections of a questionnaire, particularly in circumstances where the questions become repetitive and/or the cognitive load is large.  In order to reduce survey fatigue, it is critical to design questionnaires to be as engaging and efficient as possible; and

    (d)when an online market research questionnaire asks participants for details of prices they have charged or have paid, participants do not usually consult their records to determine what they charged or paid but rather answer from their recollection.  The answers are ultimately their guess, and perhaps their best/educated guess.  Mr MacLean stated that the Study Participants would likely have completed the Questionnaire from their recollection rather than actually consulting their records which may have negatively affected the accuracy of the results. 

    Cross-examination of Mr MacLean

1. In the first Dreyer Affidavit, Professor Dreyer opined that treatment time would vary depending on individual factors.  Professor Dreyer stated that treatment duration with braces or clear aligners depended, in part, on the frequency of adjustments (of fixed appliances) or changes (of aligners) that were required.  Professor Dreyer stated that treatment duration, with braces, is dependent on the frequency of “adjustments” performed when a patient attends an orthodontist’s clinic to have adjustments made to their fixed appliance.  Professor Dreyer’s evidence was also that the same can be said in relation to the frequency of changes of all clear aligners, including Invisalign aligners.  Professor Dreyer stated that, the more frequently an aligner or fixed appliance was changed, the greater the reduction in the duration of treatment.

2. In the Joint Expert Report, Dr Lai stated that he did not have sufficient experience with braces to be able to compare Invisalign aligners with braces.

3. I have considered the expert evidence in the opinions expressed in the Joint Expert Report in answer to question 42 and in the evidence given in the expert conclave by Drs Chan, Mahony and Vlaskalic.  I prefer the expert opinions of Drs Chan and Vlaskalic to that of Dr Mahony.  On the topic of treatment time, I found the evidence of Drs Chan and Vlaskalic to be more comprehensive than Dr Mahony’s evidence in identifying factors which impact upon treatment time using traditional metal braces as opposed to Invisalign aligners.  Drs Chan and Vlaskalic’s evidence establishes that those factors include whether there is a deep bite or open bite case, the patient’s ability to attend consultations with orthodontists to have adjustments made to their fixed appliance, patient compliance and the practitioner’s goals for the treatment. 

4. I also accept Professor Dreyer’s evidence that treatment time will vary depending on individual factors, which includes the frequency of adjustments made to fixed appliances and the frequency of changes to aligners.  The evidence of Drs Chan and Vlaskalic is consistent with Professor Dreyer’s evidence.  The evidence of Drs Chan and Vlaskalic, and Professor Dreyer establishes that Invisalign aligners could be faster than treatment with braces for some patients.

5. SDC also made submissions with respect to the expert evidence of Professor Dreyer, who was shown and commented on the Gu Article and the Buschang Article referred to in footnote 2 of the additional text accompanying the Braces Comparison Statement. 

6. Professor Dreyer was also shown and cross-examined on the Lin Article which was tendered in evidence and marked exhibit 66.  Professor Dreyer accepted that the Lin Article concluded that patients that were treated with Invisalign aligners required 4.8 months’ longer treatment time than patients with braces.  The substance of SDC’s submission was that, due to deficiencies in the studies that were the subject of the Gu Article and Buschang Article, those articles should be given no probative weight on the question of whether or not Invisalign treats orthodontic conditions faster than braces.  Instead, the Court should accept the findings of the Lin Article, which SDC characterised as containing more rigorous research findings.

7. The Buschang Article compared the time efficiency of Invisalign aligners compared to conventional braces.  The research is now eight years old and involved a comparison with a now superseded version of Invisalign aligners, which is no longer supplied to consumers.  The study involved a retrospective analysis of patients who had completed treatment.

8. The Gu Article is five years old and assesses patients who underwent orthodontic treatment between 2009 and 2014.  Like the Buschang Article, this study compared treatment time with previous versions of Invisalign aligners against treatment time with braces.  The study found that, compared to Invisalign aligners, conventional braces required 5.7 months’ longer treatment duration.

9. Professor Dreyer was not asked to advise the Court what other articles were available that might bear upon the findings in the articles shown to him and whether there was any other research which contradicts the Gu Article and the Buschang Article.  Professor Dreyer accepted, in cross-examination, that there was a “great deal” of published articles on the time required to conduct an orthodontic treatment program.  Professor Dreyer also explained that the two articles which he was asked to opine on was only a small selection of the available academic literature on this topic.  In the course of providing his evidence, Professor Dreyer did not conduct an independent literature review or meta-analysis of the research available in relation to the time efficacy of aligners.

10. Professor Dreyer’s evidence referring to the Buschang Article and the Gu Article was challenged by Dr Ackerman.  Dr Ackerman gave evidence that the findings in the Buschang Article were highly biased and the conclusions could not be relied upon.  Dr Ackerman stated that the study in the Buschang Article involved a retrospective analysis of patients who had completed treatment.  Dr Ackerman gave oral evidence that this type of research was lower on the evidence pyramid in terms of the persuasiveness and significance of the evidence.  Dr Ackerman gave evidence that the results of the Buschang Article were likely to have been influenced by treatment planning bias, in circumstances where the criteria for treatment with braces or Invisalign aligners was not exposed or explained in the research.  Dr Ackerman also stated that the Buschang Article suffered from further deficiencies.  In Dr Ackerman’s view, these deficiencies were that the Buschang study:

    (a)had no control group;

    (b)there was no “blinding” of the clinician; and

    (c)there was no randomisation of the patients or their inclusion in the braces or clear aligners group.

11. Dr Ackerman also gave evidence that the results of the study in the Gu Article were subject to the following limitations:

    (a)multiple braces systems (which were not disclosed) were used;

    (b)multiple clinicians treated patients in both groups of the study; and

    (c)the study did not state the criteria for deciding when the treatment was complete.

12. In the second Dreyer Affidavit, Professor Dreyer accepted that the Buschang Article and the Gu Article did not employ a perfect academic methodology.  However, Professor Dreyer stated that similar deficiencies can be found in all clinical treatment studies.  Professor Dreyer stated that while it is ideal to have patients be randomised into treatment groups in a clinical trial setting, to do so in circumstances where two different medical devices are used to correct malocclusion can be difficult and potentially unethical. 

13. Professor Dreyer’s evidence was that it was also difficult to implement a “control group” in a comparative clinical trial of the nature in which the Buschang study was conducted.  This is also the case, in Professor Dreyer’s view, for implementing “blinding” in order to reduce any bias which might arise from the researcher or patient knowing the treatment method allocated to them.

14. Professor Dreyer gave further evidence that, where it is not possible to implement randomisation, any possible bias that may arise towards one method of treatment over the other may be reduced if patients are selected with similar clinical features.  Often this is reflected in a study’s inclusion criteria.  Professor Dreyer’ evidence was that by limiting the selection criteria to records of patients with very similar pre-treatment conditions, the Buschang study, as much as possible, compared patients like for like that fit within the inclusion criteria.  This made them candidates for either braces or clear aligners, subject to other considerations such as compliance.  As a result, Professor Dreyer did not consider the absence of randomisation to be a flaw of the Buschang Article. 

15. Professor Dreyer reviewed the Lin Article and accepted in cross-examination that:

    (a)the purpose of the study was to measure the treatment time of patients treated with traditional braces compared to patients treated with the latest generation, as at 2022, of Invisalign aligners;

    (b)one of the inclusion criteria of patients in the study was patients with mandibular crowding of 4mm or less;

    (c)pre-treatment occlusion among patients assigned to the braces treatment group was more complex than that of patients assigned to the Invisalign Aligner Treatment group.  The difference in complexity was statistically significant;

    (d)patients treated with Invisalign aligners required 4.8 months’ longer treatment time than patients treated with braces (despite the fact that the patients treated with braces had more complete occlusion to being with); and

    (e)one of the authors of this study (Dr Peter Buschang) was the lead author of the 2014 Buschang Article.

16. The heading of the Lin Article described it as using a “randomized controlled trial” method.  Professor Dreyer accepted, in cross-examination, that a randomised control trial reduces the risk of bias on the part of the researchers, including treatment planning bias.  When asked whether Professor Dreyer accepted that the Lin Article involved a “randomised control” trial, he explained that it was a randomised trial but only to the extent that the participants in the study were selected then randomised.  More particularly, Professor Dreyer’s evidence was that the patients were selected because of particular characteristics associated with the position of their teeth, and then randomly assigned prior to treatment to either the braces group or the Invisalign aligner group for treatment.  Professor Dreyer stated that, in the Buschang Article, Gu Article and Lin Article, the patients had been selected on basically the same characteristics. Professor Dreyer also accepted that the Lin Article was a prospective study as opposed to a retrospective study.

17. For the reasons given above, I found that Dr Ackerman was not a reliable witness and was not independent of SDC.  As a consequence, Dr Ackerman’s evidence is of no probative value.

18. I accepted the expert evidence given by Professor Dreyer and, in particular, his evidence that deficiencies may be found in all clinical treatment studies. 

19. For this reason, I place greater weight on the expert evidence given by Drs Chan and Vlaskalic in the Joint Expert Report and the evidence which they gave in the expert conclave, which I have referred to above. 

20. I place little weight on the Buschang Article and the Gu Article because of the deficiencies in those articles identified by Professor Dreyer.  However, I reject SDC’s submission that the Buschang Article and the Gu Article should be given no probative weight on the question of whether or not Invisalign treats orthodontic conditions faster than braces.  The only evidence challenging the reliability of the Buschang Article and Gu Article was provided by Dr Ackerman, whose evidence I have not accepted.  The cross-examination of Professor Dreyer did not establish that the deficiencies in the Buschang Article and the Gu Article warranted a conclusion that they should be given no probative value. 

21. As to the Lin Article, I accept Professor Dreyer’s evidence that the study in the article was not an entirely “randomised” controlled trial, as patients were selected because of particular characteristics associated with the position of their teeth.  The Lin Article therefore has its own deficiencies.  Moreover, the conclusions in the Lin Article – that the patients in the study treated with braces completed treatment 4.8 months earlier than those treated with Invisalign aligners – does not detract from a conclusion that treatment with Invisalign aligners is faster than braces in some circumstances.  I am therefore not satisfied that the Lin Article establishes the falsity of the Conveyed Treatment Time Representation.

22. I am not satisfied, on the evidence, that SDC has established the falsity of the Conveyed Treatment Time Representation and that treatment time with Invisalign aligners is not faster than braces in some circumstances.

    Organic Content Representation

23. SDC alleges that during the period from July 2020 to June 2021, Invisalign published testimonials and accompanying images of social media influencers on its website.  These influencer testimonials were the basis for SDC’s claim in respect of the Organic Content Representation (Promotional Testimonials).  SDC claims that Invisalign misled consumers by representing that this content was not sponsored content.

24. The Promotional Testimonials on the Invisalign Website are not accompanied by any sponsorship disclosure, such that consumers would be aware that these testimonials were paid endorsements.  As such, SDC contends that the Invisalign Website does not inform consumers that the content is sponsored content and that Invisalign paid the influencer to promote the Invisalign brand.

25. SDC relies upon Invisalign’s Instagram page which has the same Promotional Testimonials but which are accompanied by hashtags including “#paidpartnership”, “#brandambassador” “sp” and “#spon”.  SDC alleges that hashtags such as these inform consumers that it is in fact sponsored content, and that the influencers have been paid to promote the Invisalign brand.  Invisalign’s Instagram page and the relevant posts which contain the hashtags are only visible to consumers who have an Instagram account and are logged into their account.

26. SDC relies upon the evidence of Ms Rivera, Invisalign Australia’s Associate Marketing Director, that it is customary for social media posts which contain paid content to be accompanied by a sponsorship disclaimer which puts the viewer on notice that such content is, in effect, a paid advertisement.  That knowledge, SDC submits, would be attributable to the ordinary and reasonable consumer.  In this context, SDC submits that by publishing the Promotional Testimonials on the Invisalign Website without disclosing the nature of the sponsorship, Invisalign has impliedly misrepresented to consumers that the Promotional Testimonials were organic rather than sponsored content.

27. SDC has led no evidence to support the contention that an ordinary or reasonable consumer would be misled by the publication of the Promotional Testimonials. 

28. I accept Ms Rivera’s evidence that it is Invisalign’s usual practice to communicate to consumers when a person has been compensated for the use of their photograph or their testimonial on social media.  Ms Rivera explained that this is because social media users are exposed to a feed of posts from a variety of sources: friends, family, accounts they follow (celebrities and corporate entities) as well as advertisements and sponsored content.

29. Ms Rivera’s evidence was that it was not customary for the same approach to be taken on Invisalign’s own company website.  The basis for the difference is that the company’s website is an environment controlled by Invisalign.  I accept that the ordinary and reasonable consumer visiting Invisalign’s website does not need to be informed that they are being exposed to information and promotional content about Invisalign and its products as that is obvious from the platform they are on.  I also accept that the ordinary, reasonable consumer in accessing Invisalign’s website would expect that the promotional advertisements and testimonials would be paid for and sponsored by Invisalign.

30. I find that the Organic Content Representation is not made out on the evidence and this part of SDC’s cross-claim must fail.

    Comfort Representations

31. SDC relies upon two Facebook posts from Invisalign Australia’s Facebook page, which were annexed to the Affidavit of Mr Bodulovic, which was marked exhibit 82. 

32. The first Facebook post took place on18 May 2019.  The post stated “Invisalign aligners are made with our flexible proprietary Smart Track material, which makes them comfortable to wear, insert and remove, unlike other teeth straightening solutions” (Comfort Comparison Statement).

33. The 8 May 2019 Facebook post relied upon by SDC AU has reproduced below:

34. The first Facebook post took place on 4 March 2020.   The post stated “With the world’s most advanced clear aligner system, you can straighten your teeth the most comfortable and convenient way” (Most Advanced Aligner Statement).

35. The 4 March 2020 Facebook post relied upon by SDC AU has reproduced below:

36. SDC contends that both statements represent to an ordinary and reasonable consumer that Invisalign aligners are more comfortable than all other teeth straightening options including other clear aligners in the Australian market, and/or that clear aligners other than Invisalign aligners are not comfortable to wear, insert or remove (Comfort Representations).

37. SDC contends that the Comfort Representations are conveyed in the Comfort Comparison Statement by reason of the reference to comfort and the juxtaposition with “other teeth straightening solutions”, which is unqualified and sufficiently broad to draw in all other teeth straightening options, including other brands of clear aligners.

38. SDC contends that the Comfort Representations are conveyed in the Most Advanced Aligner Statement by the statement of comparison to other clear aligners (“the world’s most advanced clear aligner system”), which is then used as a platform for the statement that Invisalign aligners are “the most comfortable”, being more comfortable than other clear aligners.

39. The 18 May 2019 Facebook post appeared with an electronic file (a GIF) which displayed a moving image on a loop which showed a woman removing Invisalign aligners from her Invisalign case and provided a hyperlink to the Invisalign Website with text “Find out more about Invisalign treatment” displayed.  A screenshot of this GIF is provided below. 

40. Contrary to SDC’s submission, I am of the opinion that this Facebook post does not convey that Invisalign aligners are more comfortable than all other teeth straightening options, including other clear aligners.  I am also of the view that it does not convey that clear aligners other than Invisalign aligners are not comfortable to wear, insert or remove. 

41. In my view, the only comparison that is made is based on an undisputed distinguishing feature between Invisalign aligners and fixed appliances (such as braces) namely, the capacity for a patient to insert and remove the clear aligners.  There is, in my opinion, no comparison between Invisalign aligners and all other aligners available to Australian consumers, given they too are to be inserted and removed and are not “fixed”.

42. I am not satisfied that the 18 May 2019 Facebook post makes any comparison to other brands of clear aligners.  The statement in the post is, in my view, ambiguous when it refers to “unlike other teeth straightening solutions”.

43. The expert evidence established that fixed appliances such as braces are more aggravating to the soft tissues of the mouth and cannot be removed without a dentist’s assistance. 

44. Drs Chan and Vlaskalic expressed the opinion that Invisalign branded clear aligners are more comfortable than fixed appliances: Joint Expert Report, question 43.  Dr Vlaskalic noted at question 43 in the Joint Expert Report, that “…literature supports the finding that Invisalign aligners are more comfortable than fixed appliances at the initiation of treatment…”.

45. Drs Mahony and Lai did not disagree with the proposition that clear aligners were more comfortable than fixed appliances: Joint Expert Report, question 43.

46. To the extent that the Comfort Representations compare Invisalign aligners with fixed appliances such as braces, the expert evidence establishes that Invisalign aligners are more comfortable than fixed appliances and as such the Comfort Representations are not false, misleading or deceptive.

47. SDC’s submissions with respect to the Most Advanced Aligner Statement from the 4 March 2020 Facebook post explicitly uses the words “the most comfortable …”.  However, as can be seen in the image below, the word “most” does not appear in the context which is submitted by SDC.  This post is shown below. 

1. As can be seen above, no express comparison of comfort is made between Invisalign aligners and SDC aligners or other brands of aligners in the 4 March 2020 Facebook post. 

2. I am not satisfied that the Comfort Representations arise from the 4 March 2020 Facebook post. 

3. I accept Invisalign’s submission that, at its highest, the 4 March 2020 Facebook post conveys that:

   (a)the Invisalign system is the most advanced clear aligner system (a representation which SDC does not take issue with); and

   (b)treatment with the Invisalign system is a comfortable and convenient way to straighten your teeth.

4. Insofar as SDC relies upon the Most Advanced Aligner Statement in the 4 March 2020 Facebook post, I am not satisfied that the statement conveys to the ordinary and reasonable consumer the alleged Comfort Representations.

   Predictability Representation

5. The “Predictability Representation” is alleged by SDC to arise from a brochure entitled “Get ready for something great.  Start with your smile” which was first published in 2017 and was last published in July 2019.

6. On page 1 of the brochure, there is a series of bullet points set out under the heading “The advantages of Invisalign treatment”.  The fourth bullet point states:

   Get straighter teeth more comfortably and predictably thanks to innovative SmartForce and SmartTrack® technologies in Invisalign Aligners.

7. SDC alleges that this statement conveys a representation that Invisalign aligners straighten teeth more predictably than traditional metal braces (Predictability Representation).

8. I do not accept that the Predictability Representation is conveyed by the above text either alone or in the context of the brochure as a whole.  There is no express or implied statement as to the predictability of the Invisalign aligner system as compared with braces.  Such an imputation does not arise because another bullet point on the page refers to metal braces in the context of a statement about the suitability of Invisalign aligners for persons with an active lifestyle. 

9. The context of the brochure as a whole supports this interpretation.  Pages 1-2 of the brochure predominantly feature the following description of the Invisalign system in response to the question (set out as a heading) “What is Invisalign?”:

   The Invisalign system is a virtually invisible treatment that uses an innovative approach to gently and yet effectively straighten your teeth.  Through a series of customer-made, removable aligners made with unique SmartForce® technology, the Invisalign system gradually and predictably moves your teeth to the desired position.

   (Emphasis added)

10. The concept of predictability is further addressed in the second bullet point under the heading “How does the Invisalign system work?” which describes the use of Invisalign’s technology to create a customised treatment plan for each patient.  This, in my view, is the context in which “predictably” is used in the brochure.

11. I am not satisfied on the evidence that the statement in the brochure would convey to the ordinary and reasonable consumer that Invisalign aligners straighten teeth more predictably than traditional braces.

    DISPOSITION

12. For the reasons set out above, I find that Invisalign’s claim against SDC must fail.  Costs should follow the event. 

13. I also find that SDC’s cross-claim against Invisalign must fail.  Costs should also follow that event.

14. I make orders accordingly.

I certify that the preceding one thousand and eleven (1011) numbered paragraph is a true copy of the Reasons for Judgment of the Honourable Justice Anderson.

Associate:

Dated: 5 May 2023

ANNEXURE A

LIST OF AFFIDAVITS TENDERED IN EVIDENCE

ANNEXURE B

LIST OF EXHIBITS TENDERED IN EVIDENCE

ANNEXURE C

PROMOTIONAL MATERIAL ADMITTED INTO EVIDENCE RELIED ON BY INVISALIGN IN ITS CLAIM AGAINST SDC