Secretary, Department of Health v Oxymed Australia Pty Ltd

[2021] FCA 1518

FEDERAL COURT OF AUSTRALIA

Secretary, Department of Health v Oxymed Australia Pty Ltd [2021] FCA 1518  

File number(s):

VID 558 of 2020

Judgment of:

ROFE J

Date of judgment:

3 December 2021

Catchwords:

HEALTH LAW – where respondents contravened s 42DLB(1) of the Therapeutic Goods Act 1989 (Cth) by advertising unregistered medical devices and making prohibited and restricted representations on the internet – where conduct was accepted by respondents but number of contraventions in dispute – whether conduct considered a continuous offence

PENALTY - amount of pecuniary penalty to be imposed pursuant to s 42Y of Therapeutic Goods Act 1989 (Cth) – course of conduct principle – totality principle – general and specific deterrence

Legislation:

Crimes Act 1914 (Cth)

Federal Court of Australia Act1976 (Cth)

Therapeutic Goods Act 1989 (Cth)

Therapeutic Goods Advertising Code (No 2) 2018 (Cth)

Therapeutic Goods Regulations 1990 (Cth)

Trade Practices Act1974 (Cth)

Health Professions Registration Act 2005 (Vic)

Cases cited:

Australian Building and Construction Commission v Construction, Forestry, Mining and Energy Union (2017) 254 FCR 68

Australian Building and Construction Commissioner v Construction, Forestry, Mining and Energy Union (2018) 262 CLR 157

Australian Competition and Consumer Commission v Bupa Aged Care Australia Pty Ltd [2020] FCA 602

Australian Competition and Consumer Commission v Coles Supermarkets Australia Pty Ltd [2015] FCA 330

Australian Competition and Consumer Commission v Leahy Petroleum Pty Ltd (No 2) (2005) 215 ALR 281

Australian Competition and Consumer Commission v Lorna Jane Pty Ltd [2021] FCA 852

Australian Competition and Consumer Commission v Telstra Corporation Limited [2010] FCA 790

Australian Competition and Consumer Commission v Turi Foods Pty Ltd (No 5) [2013] FCA 1109

Australian Competition and Consumer Commission v Universal Music Australia Pty Ltd (No 2) (2002) 201 ALR 618

Australian Securities and Investments Commission v Westpac [2019] FCA 2147

Chiropractic Board of Australia v Hooper (Review and Regulation) [2013] VCAT 878

Chiropractic Board of Australia v Hooper (Review and Regulation) [2013] VCAT 1346

Director of Consumer Affairs Victoria v Gibson (No 3) [2017] FCA 1148

Ex parte Barelli’s Bakeries Pty Ltd [1965] VR 615

Markarian v The Queen (2005) 228 CLR 357

Mornington Inn v Jordan (2008) 247 ALR 714

NW Frozen Foods Pty Ltd v ACCC (1996) 71 FCR 285

Pattinson v Australian Building and Construction Commissioner [2020] FCAFC 177

Secretary, Department of Health v Evolution Supplements Australia Pty Ltd (No 2) [2021] FCA 872

Secretary, Department of Health v Evolution Supplements Australia Pty Ltd [2021] FCA 74

Secretary, Department of Health v Peptide Clinics Australia Pty Ltd [2019] FCA 1107

Singtel Optus Pty Ltd v Australian Competition and Consumer Commission (2012) 287 ALR 249

TPG Internet Pty Ltd v Australian Competition and Consumer Commission (2012) 210 FCR 277

Trade PracticesCommission v CSR Ltd [1991] ATPR 41-076

Wong v The Queen (2001) 207 CLR 584

Division:

General Division

Registry:

Victoria

National Practice Area:

Commercial and Corporations

Sub-area:

Regulator and Consumer Protection

Number of paragraphs:

276

Date of hearing:

12–13 August 2021

Counsel for the Applicant:

Dr I Freckelton AO QC with Ms S Hogan

Solicitor for the Applicant:

Australian Government Solicitor

Counsel for the Respondents:

Mr C Mandy SC with Ms A Harrold

Solicitor for the Respondents:

Furstenberg Law

ORDERS

VID 558 of 2020

BETWEEN:

SECRETARY OF THE DEPARTMENT OF HEALTH

Applicant

AND:

OXYMED AUSTRALIA PTY LTD

First Respondent

MALCOLM HOOPER

Second Respondent

ORDER MADE BY:	ROFE J
DATE OF ORDER:	3 DECEMBER 2021

THE COURT DECLARES THAT:

1.Between 20 February 2020 and 17 August 2020:

(a)the First Respondent and Second Respondent, by advertising devices intended to administer hyperbaric oxygen therapy (HBOT Devices) on its website at (Website), in circumstances where s 42DLB(9) of the Therapeutic Goods Act 1989 (Cth) (TG Act) applies because the advertisement referred to HBOT Devices that are:

(i)“therapeutic goods” within the meaning of s 3 of the TG Act;

(ii)not entered in the Australian Register of Therapeutic Goods maintained by the Applicant under s 9A of the TG Act (Register); and

(iii)not the subject of an exemption, approval or authority under the TG Act nor an exemption, approval or authority under regulations under the TG Act within the meaning of r 7(i) of the Therapeutic Goods Regulations 1990 (Cth) (TG Regulations),

in respect of each advertisement, contravened s 42DLB(1) of the TG Act.

(b)the Second Respondent aided, abetted, counselled or procured the First Respondent’s contraventions of s 42DLB(1) of the TG Act referred to in paragraph 1(a), and was therefore involved in those contraventions for the purpose of s 42YC of the TG Act.

2.Between 13 March 2020 and 3 April 2020:

(a)the First Respondent and Second Respondent, by advertising HBOT Devices on its Facebook page located at facebook.com/oxymedaustralia (Facebook Page), in circumstances where s 42DLB(9) of the TG Act applies because the advertisement referred to HBOT Devices that are:

(i)“therapeutic goods” within the meaning of s 3 of the TG Act;

(ii)not entered in the Australian Register of Therapeutic Goods maintained by the Applicant under s 9A of the TG Act (Register); and

(iii)not the subject of an exemption, approval or authority under the TG Act nor an exemption, approval or authority under regulations under the TG Act within the meaning of r 7(i) of the TG Regulations,

in respect of each advertisement, contravened s 42DLB(1) of the TG Act.

(b)the Second Respondent aided, abetted, counselled or procured the First Respondent’s contraventions of s 42DLB(1) of the TG Act referred to in paragraph 2(a), and was therefore involved in those contraventions for the purpose of s 42YC of the TG Act.

3.Between 11 March 2020 and 17 August 2020:

(a)the First Respondent and Second Respondent, by advertising, or causing to be advertised HBOT Devices, on the Website and in a manner that contained representations that referred to the diseases, conditions, ailments or defects listed in Annexure A hereto, and in circumstances where s 42DLB(4) of the TG Act applies because:

(i)each representation in respect of each of the said diseases, conditions, ailments or defects is, by s 28 of the Therapeutic Goods Advertising Code (No 2) 2018 (Cth) (TG Code), a restricted representation within the meaning of s 42DD of the TG Act;

(ii)no approval under s 42DF of the TG Act was in force in respect of any of the restricted representations; and

(iii)no permission under s 42DK of the TG Act was in force in respect of any of the restricted representations,

in respect of each advertisement, contravened s 42DLB(1) of the TG Act.

(b)the Second Respondent aided, abetted, counselled or procured the First Respondent’s contraventions of s 42DLB(1) of the TG Act referred to in paragraph 3(a), and was therefore involved in those contraventions for the purpose of s 42YC of the TG Act.

4.Between 13 March 2020 and 3 April 2020:

(a)the First Respondent and Second Respondent, by advertising, or causing to be advertised, HBOT Devices on the Facebook Page and in a manner that contained representations that referred to the diseases, conditions, ailments or defects listed in Annexure A hereto, and in circumstances where s 42DLB(4) of the TG Act applies because:

(i)each representation in respect of each of the said diseases, conditions, ailments or defects is, by s 28 of the TG Code, a restricted representation within the meaning of s 42DD of the TG Act;

(ii)no approval under s 42DF of the TG Act was in force in respect of any of the restricted representations; and

(iii)no permission under s 42DK of the TG Act was in force in respect of any of the restricted representations,

in respect of each advertisement, contravened s 42DLB(1) of the TG Act.

(b)the Second Respondent aided, abetted, counselled or procured the First Respondent’s contraventions of s 42DLB(1) of the TG Act referred to in paragraph 4(a), and was therefore involved in those contraventions for the purpose of s 42YC of the TG Act.

5.Between 20 February 2020 and 19 June 2020:

(a)the First Respondent and Second Respondent, by advertising or causing to be advertised HBOT Devices on the Website, in a manner that contained representations regarding the cure, prevention, diagnosis (including screening), monitoring or susceptibility of, or pre-disposition to, the diseases listed in Annexure B hereto, and in circumstances where s 42DLB(2) of the TG Act applies because:

(i)each representation in respect of each of the diseases is, by r 6B(1)(b) of the TG Regulations and s 30 of the TG Code, a prohibited representation within the meaning of s 42DJ of the TG Act; and

(ii)no permission under s 42DK of the TG Act was in force in respect of any of the prohibited representations,

in respect of each advertisement, contravened s 42DLB(1) of the TG Act.

(b)the Second Respondent aided, abetted, counselled or procured the First Respondent’s contraventions of s 42DLB(1) of the TG Act referred to in paragraph 5(a), and was therefore involved in those contraventions for the purpose of s 42YC of the TG Act.

6.On 3 April 2020:

(a)the First Respondent and Second Respondent, by advertising or causing to be advertised HBOT Devices on the Website, in a manner that contained representations regarding the cure, prevention, diagnosis including screening), monitoring or susceptibility of, or pre-disposition to, Post Traumatic Stress Disorder, and in circumstances where s 42DLB(2) of the TG Act applies because:

(i)each representation in respect of each of the diseases is, by r 6B(1)(b) of the TG Regulations and s 30 of the TG Code, a prohibited representation within the meaning of s 42DJ of the TG Act; and

(ii)no permission under s 42DK of the TG Act was in force in respect of any of the prohibited representations,

in respect of each advertisement, contravened s 42DLB(1) of the TG Act.

(b)the Second Respondent aided, abetted, counselled or procured the First Respondent’s contraventions of s 42DLB(1) of the TG Act referred to in paragraph 6(a), and was therefore involved in those contraventions for the purpose of s 42YC of the TG Act.

AND THE COURT ORDERS THAT:

Injunctions

7.Pursuant to s 42YN(1) of the TG Act, the First Respondent be restrained, for a period of seven years from the date of this order (whether by itself, its servants or agents or otherwise) from:

(a)advertising, or causing or permitting the advertising of, any HBOT Devices unless the relevant HBOT Device is first entered in the Register;

(b)advertising, or causing or permitting the advertising of, any HBOT Devices in a manner that contains references to any serious form of a disease, condition, ailment or defect, including but not limited to those listed in Annexure A, without an approval under s 42DF or a permission under s 42DK of the TG Act in force in relation to the restricted representation;

(c)advertising, or causing or permitting the advertising of, any HBOT Devices in a manner that contains references to:

(i)neoplastic disease;

(ii)sexually transmitted disease;

(iii)human immunodeficiency virus and acquired immune deficiency syndrome (HIV AIDS);

(iv)hepatitis C virus (HCV); or

(v)mental illness;

including but not limited to those in Annexure B, without permission under s 42DK of the TG Act.

8.Pursuant to s 42YN(1) of the TG Act, the Second Respondent be restrained, for a period of seven years from the date of this order (whether by himself, his servants or agents or otherwise) from:

(a)advertising, or causing or permitting the advertising of, any HBOT Devices unless the relevant HBOT Device is first entered in the Register;

(b)advertising, or causing or permitting the advertising of, any HBOT Devices in a manner that contains references to any serious form of a disease, condition, ailment or defect, including but not limited to those listed in Annexure A, without an approval under s 42DF or a permission under s 42DK of the TG Act in force in relation to the restricted representation;

(c)advertising, or causing or permitting the advertising of, any HBOT Devices in a manner that contains references to:

(i)neoplastic disease;

(ii)sexually transmitted disease;

(iii)human immunodeficiency virus and acquired immune deficiency syndrome (HIV AIDS);

(iv)hepatitis C virus (HCV); or

(v)mental illness;

including but not limited to those in Annexure B, without permission under s 42DK of the TG Act.

(d)aiding, abetting, counselling or procuring any advertising of HBOT Devices in any of the circumstances referred to in paragraphs 8(a) to 8(c) above.

Pecuniary penalties

9.Within 30 days of the date of this order, the First Respondent pay a pecuniary penalty in the sum of $2,000,000 to the Commonwealth of Australia pursuant to s 42Y(2) of the TG Act, in respect of the contraventions of the TG Act declared in paragraphs 1(a), 2(a), 3(a), 4(a), 5(a) and 6(a) above.

10.Within 30 days of the date of this order, the Second Respondent pay a pecuniary penalty in the sum of $1,000,000 to the Commonwealth of Australia pursuant to s 42Y(2) of the TG Act, in respect of the contraventions of the TG Act declared in paragraphs 1(b), 2(b), 3(b), 4(b), 5(b) and 6(b) above.

Costs

11.The Respondents pay the Applicant’s costs of and incidental to the proceedings.

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

Annexure A

1.Alzheimer’s disease

2.Amyotrophic lateral sclerosis

3.Autism spectrum disorders

4.Autoimmune illness

5.Back pain

6.Brain injury

7.Carbon monoxide (CO) poisoning

8.Cellulitis

9.Cerebral malaria

10.Cerebral palsy

11.Near drowning (submersion injuries)

12.Chronic fatigue illness

13.Chronic infections

14.Complex pain syndrome

15.Concussion disability

16.Coronavirus

17.Crohn’s disease

18.Crush injury

19.Cytokine storm syndrome

20.Dementia / cognitive decline

21.Disc prolapse

22.Failed back surgery

23.Fibromyalgia

24.Fracture repair

25.Gadolinium poisoning

26.Hearing loss

27.Hospital infections (MRSA, VRE)

28.Irritable bowel syndrome

29.Infertility

30.Kidney disease

31.Live disease

32.Lyme disease

33.Macular degeneration

34.Multiple sclerosis

35.Muscular dystrophy

36.Motor neuron disease

37.Osteoporosis

38.Pancreatitis

39.Paraplegia, quadriplegia

40.Psoriasis

41.Radiation necrosis

42.Reflex sympathetic dystrophy

43.Spinal cord injury

44.Spinal instability

45.Sensorineural hearing loss

46.Stroke

47.Tarlov cyst

48.Traumatic brain injury

49.Ulcerative colitis

Annexure B

1.HIV/AIDS

2.Cancer

3.Depression

4.Glioblastoma

5.Post-traumatic stress disorder

REASONS FOR JUDGMENT

ROFE J:

INTRODUCTION

1. In this matter the Applicant, the Secretary of the Department of Health (the Secretary) seeks declaratory relief, injunctions and pecuniary penalties against the Respondents for contraventions of s 42DLB(1) of the Therapeutic Goods Act 1989 (Cth) (the TGAct).

2. The Secretary alleges that the First Respondent, Oxymed Australia Pty Ltd (Oxymed), has contravened s 42DLB(1) of the TG Act by advertising conduct carried out during a period from at least 20 February 2020 to 17 August 2020 (the Relevant Period). The Secretary also alleges that the Second Respondent, Mr Hooper, the sole director and secretary of Oxymed, has also contravened s 42DLB(1) of the Act, or alternatively that he is liable for aiding and abetting the contravention by Oxymed.

3. The conduct alleged to contravene s 42DLB(1) of the TG Act constituted posts appearing on two digital platforms operated by the Respondents: the Oxymed website (at (the Website) and the Oxymed Facebook Page (located at (the Facebook Page) during the Relevant Period.

4. Oxymed promoted hyperbaric oxygen therapy (HBOT) and hyberbaric oxygen chambers (HBOT devices) by posting on its Website and Facebook Page about HBOT as a treatment for a variety of conditions and illnesses such as Alzheimer’s disease, cerebral palsy, dementia, COVID-19, stroke, HIV/AIDS, cancer, depression and post-traumatic stress disorder. The HBOT devices were not registered on the Australian Therapeutic Goods Register (ARTG), or the subject of any exemption or permission from the Secretary at the time of the posts.

5. The Respondents made a number of admissions set out in the Statement of Agreed Facts and Admissions (SAFA) annexed to these reasons, including that the posts constituted advertisements for the purposes of s 42DLB of the TG Act. Oxymed and Mr Hooper admitted that they advertised or caused to be advertised three categories of advertisements that contravened the TG Act: (a) advertisements referring to the unregistered HBOT devices; (b) advertisements containing restricted representations; and/or (c) advertisements containing prohibited representations.

6. I consider the conduct of Oxymed and Mr Hooper in more detail below.

7. There was no dispute as to the facts establishing the contraventions. The relevant facts for liability were the subject of agreement between the parties and they are set out in the SAFA and the Supplementary Statement of Agreed Facts (the SSAFA) filed by the parties, both of which are annexed to these reasons.

8. Dispute remained as to the quantification of the contraventions and as to the construction of s 42DLB(1) of the TG Act, in particular whether that section contemplated a continuing contravention absent any express legislative requirement.

9. The Secretary alleged that there was a total of 1851 unique contraventions. Details of the advertisements, the conditions, the social media platforms and the date range of the advertisements constituting the contraventions were set out in an annexure to the Secretary’s submissions.

10. The Secretary sought pecuniary penalties against Oxymed and Mr Hooper within the following ranges (after any discounts for totality and co-operation have been applied):

    (a)$5 million to $10 million for Oxymed; and

    (b)$500,000 to $750,000 for Mr Hooper.

11. Subsequent to the hearing the Respondents provided a “table of unique posts” which sought to remove duplicate posts from those listed in Annexure 1 to the Secretary’s submissions. On the Respondents’ analysis there are 176 “unique posts”. The Secretary objected to the methodology used by the Respondent to identify “unique posts”.

12. For the reasons that follow, I have determined that:

    (a)Oxymed is liable to pay $2 million as a penalty pursuant to s 42Y of the TG Act for its breaches of s 42DLB(1); and

    (b)Mr Hooper is liable to pay $1 million as a penalty pursuant to s 42Y of the TG Act for his breaches of s 42DLB(1).

13. I will also make orders for declarations and injunctions in the form handed up by the parties.

1. The hearing, which was a trial as to the question of penalty only, occupied one and a half days. Due to the exigencies of the COVID-19 pandemic restrictions, the hearing took place using Microsoft Teams.

   THE LEGISLATION

2. Before considering the contraventions and appropriate penalties, it is useful to set out the relevant parts of the TG Act, the Therapeutic Goods Regulations 1990 (Cth) (TG Regulations) and the Therapeutic Goods Advertising Code (No.2) 2018 (Cth) (TG Advertising Code) applicable to the advertising of therapeutic goods.

3. At the outset, s 4(1) of the TG Act states that one of its objects is to:

   (a) provide for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are:

   (i)used in Australia, whether produced in Australia or elsewhere; or

   (ii)exported from Australia;

   …

4. The TG Advertising Code relates to the advertising of therapeutic goods, with s 6 providing that the TG Advertising Code applies to advertising of therapeutic goods that is not directed exclusively to health professionals or that is not part of a public health campaign.

5. The objects of the TG Advertising Code in s 5 include to ensure that advertising of therapeutic goods to consumers is conducted in a manner that:

   (a)promotes the safe and proper use of therapeutic goods by minimising their misuse, overuse or underuse; and

   (b)is ethical and does not mislead or deceive the consumer or create unrealistic expectations about product performance; and

   (c)supports informed health care choices; and

   (d)is not inconsistent with current public health campaigns.

6. Section 10 of the TG Advertising Code provides:

   Advertising for therapeutic goods must:

   (a)       support the safe and proper use of therapeutic goods by:

   (i)presenting the goods in accordance with directions or instructions for use; and

   (ii)not exaggerating product efficacy or performance; and

   (b)not be likely to lead to people delaying necessary medical attention or delaying the use of, or failing to use, treatment prescribed by a medical practitioner; and

   (c)       not encourage inappropriate or excessive use of the therapeutic goods; and

   (d)      not contain any claim, statement, implication or representation that:

   (i)the therapeutic goods are safe or that their use cannot cause harm, or that they have no side-effects; or

   (ii)the therapeutic goods are effective in all cases of a condition or that the outcome from their use is a guaranteed or sure cure; or

   (iii)the therapeutic goods are infallible, unfailing, magical or miraculous; or

   (iv)harmful consequences may result from the therapeutic goods not being used — unless the claim, statement, implication or representation is permitted under section 42DK of the Act or approved under section 42DF of the Act.

7. Against this backdrop, the Secretary alleges that Oxymed and Mr Hooper contravened s 42DLB(1) of the TG Act. Section 42DLB is the general civil penalty provision relating to advertisements of therapeutic goods.

8. Section 42DLB sits within Part 5-1 of the TG Act. Chapter 5 of the TG Act is entitled “[a]dvertising, counterfeit therapeutic goods and product tampering”, and Part 5-1 applies to the advertising of therapeutic goods. The terms “advertise” and “therapeutic goods” are defined in s 3:

   advertise, in relation to therapeutic goods, includes the making of any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design:

   (a)       is on the label of the goods; or

   (b)      is on the package in which the goods are contained; or

   (c)       is on any material included with the package in which the goods are contained.

   …

   therapeutic goods means goods:

   (a)that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be:

   (i)        for therapeutic use;

   …

   and includes biologicals, medical devices and goods declared to be therapeutic goods under an order in force under section 7…

9. The term “therapeutic use” is also defined in s 3 and includes use in connection with:

   (a)preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or

   (b)       influencing, inhibiting or modifying a physiological process in persons;

   …

10. Section 42DLB(1) of the TG Act is the general civil penalty provision relating to advertisements and provides that:

    a person contravenes this subsection if:

    (a)       the person:

    (i)        advertises, by any means, therapeutic goods; or

    (ii)       causes the advertising, by any means, of therapeutic goods; and

    (b) subsection (2), (3), (4), (5), (6), (7), (8) or (9) applies to the advertisement (the “contravening provisions”).

11. The parties agree that the Respondents engaged in conduct in contravention of s 42DLB(1) by placing various advertisements to which subsections (2), (4) and/or (9) applied. These “contravening provisions” are summarised in turn below.

12. As I explain further, the parties agree that Oxymed contravened s 42DLB(1), and therefore the Court is empowered by s 42Y of the TG Act to impose a pecuniary penalty. Furthermore, the parties agree that Mr Hooper aided, abetted, counselled or procured Oxymed’s contraventions of s 42DLB(1), and was therefore involved in the conduct and subject to the operation of the TG Act by reason of s 42YC.

13. The maximum penalty for each contravention of s 42DLB(1) is 5,000 penalty units for an individual and 50,000 for a body corporate. Section 4AA of the Crimes Act 1914 (Cth) relevantly provides that unless contrary intention appears, a “penalty unit” is $210, or, from 1 July 2020, $222 (the increased figure only applies to breaches that occurred after this date).

14. Therefore, the maximum penalty for each contravention is:

    (a)as against Oxymed, $10.5 million (or $11.1 million for contraventions after 1 July 2020); and

    (b)as against Mr Hooper, $1.05 million (or $1.11 million for contraventions after 1 July 2020).

15. Section 42YN of the TG Act also empowers the Court to grant an injunction to restrain a person from engaging in conduct that contravenes the TG Act or TG Regulations, where that person has engaged in or proposes to engage in such conduct.

    Section 42DLB(2): “prohibited representations”

16. Section 42DLB(2) of the TG Act applies to an advertisement if it contains a “prohibited representation” about therapeutic goods where no permission has been granted by the Secretary under s 42DK; or where such a permission has been granted but the prohibited representation is not in accordance with that permission.

17. Section 42DJ(1) provides that for the purposes of Part 5-1, a “prohibited representation” is a representation about therapeutic goods of a kind specified in the TG Regulations. Regulation 6B states that “prohibited representations” include the representations described in s 30 of the TG Advertising Code.

18. Section 30 of the TG Advertising Code deals with “prohibited representations” for the purpose of regulation 6B of the TG Regulations (and in turn, s 42DLB(2) of the TG Act). “Prohibited representations” relevantly include any representations regarding the treatment, cure, prevention, diagnosis (including screening), monitoring or susceptibility of, or pre-disposition to, the following diseases:

    (i)neoplastic disease;

    (ii)sexually transmitted diseases;

    (iii)human immunodeficiency virus and acquired immune deficiency syndrome (HIV AIDS);

    (iv)hepatitis C virus (HCV); and

    (v)mental illness.

    Section 42DLB(4): “restricted representations”

19. Section 42DLB(4) of the TG Act applies to an advertisement if it contains a “restricted representation” about therapeutic goods where no approval under s 42DF nor permission under s 42DK is in force; or where such an approval or permission is in force but the restricted representation is not in accordance with that approval or permission.

20. A “restricted representation” is defined in s 42DD as a representation in an advertisement about therapeutic goods that refers to a form of a disease, condition or ailment identified by the TG Advertising Code as a “serious form” of that disease, condition or ailment.

21. Section 28(1) of the TG Advertising Code states that subject to subsection (2), a form of a disease, condition or ailment is a “serious form” for the purposes of s 42DD of the TG Act if:

    (a)it is medically accepted that the form requires diagnosis or treatment or supervision by a suitably qualified health professional, except where the form has been medically diagnosed and medically accepted as being suitable for self-treatment and management; or

    (b)there is a diagnostic (including screening), preventative, monitoring, susceptibility or pre-disposition test available for the form (including a self-administered test), which requires medical interpretation or follow-up.

22. Section 28(2) of the TG Advertising Code provides that a serious form of a disease or condition does not include pregnancy, or any of the diseases mentioned in s 30 of the TG Advertising Code (which, as set out above, relates to prohibited representations).

    Section 42DLB(9): advertising unregistered therapeutic goods

23. Section 42DLB(9) of the TG Act applies to the advertising of therapeutic goods that are not entered on the ARTG and that are prescribed by the Regulations for the purpose of this subsection.

24. Regulation 7 of the TG Regulations prescribes certain therapeutic goods for the purpose of s 42DLB(9). Relevantly, regulation 7(i) prescribes therapeutic goods that are not the subject of an exemption, approval or authority under the TG Act or the TG Regulations. In other words, s 42DLB(9) and regulation 7(i) prohibit the advertising of therapeutic goods which are not entered on the ARTG, or otherwise subject of an exemption, approval or authority.

    THE EVIDENCE

25. The Secretary relied on the following evidence:

    (a)Two affidavits of Mr Ian Wooldridge, currently a lead investigator with Consumer Affairs, dated 19 August 2020 and 24 May 2021. At the time he made his affidavits, Mr Wooldridge was an Advertising Investigator in the Advertising, Compliance and Investigations Section (ACIS) of the Regulatory Compliance Branch of the Therapeutic Goods Administration (TGA). Mr Wooldridge annexed screen captures he had taken of the Website and the Facebook Page between 20 February 2020 and 24 May 2021. In his first affidavit, Mr Wooldridge explained the methods he used to take the screen captures, and annexed a number of letters from the TGA to Mr Hooper and Oxymed taken from the TGA’s electronic files and an e-mail inbox used by ACIS officers.

    (b)One affidavit of Ms Gluer, a lawyer with the Australian Government Solicitor (AGS), dated 20 August 2020. Ms Gluer had carriage of this matter for the Secretary. Ms Gluer’s affidavit annexed an expert report from Dr Brownscombe, two VCAT decisions relating to Mr Hooper and his previous company, HyperMED Neurorecovery Australia Pty Ltd, and copies of the five infringement notices served by the TGA on the Respondents.

    (c)One affidavit of Mr Matthew Garey, a Senior Executive lawyer with the AGS, dated 28 May 2021. Mr Garey’s affidavit annexed correspondence from the AGS to the Respondents’ lawyers relating to the Website being back online as at 18 January 2021.

    (d)Expert evidence of Dr Jeffrey Brownscombe, a registered medical practitioner and the Assistant Director and Senior Medical Adviser at the Devices Clinical Section in the Medical Devices Authorisation Branch of the TGA. Dr Brownscombe prepared a first report dated 20 July 2020 and two supplementary reports which were annexed to his affidavit dated 4 February 2021.

    (e)Expert evidence of Professor Michael Bennett, the Conjoint Professor of Anaesthesia and Hyperbaric Medicine at the Prince of Wales Clinical School UNSW Faculty of Medicine in Sydney. Professor Bennett is also the Academic Head of Anaesthesia at the Prince of Wales Hospital and a clinician at the Prince of Wales Hospital in both Anaesthesia and Diving and Hyperbaric Medicine. Professor Bennett made one report which was annexed to his affidavit of 28 May 2021.

26. Oxymed and Mr Hooper relied on the affidavit of Mr Avi Furstenberg made 13 July 2021. Mr Furstenberg is a principal at Furstenberg Law, and had carriage of this matter for the Respondents. Mr Furstenberg also has the carriage of a separate Worksafe prosecution proceeding against Oxymed and Mr Hooper in the County Court of Victoria.

27. Mr Furstenberg gave evidence as to the state of Mr Hooper’s finances. Mr Hooper’s representation in the County Court proceeding was funded by Victoria Legal Aid, with the condition that Mr Hooper repay the sum of $171,054 in monthly instalments of $200. Mr Furstenberg’s evidence is that Mr Hooper also has a number of outstanding costs orders against him in relation to “other matters”. A letter from Holding & Redlich annexed to Mr Furstenberg’s affidavit refers to five costs orders related to the VCAT Proceedings (discussed below), and seeks payment of $590,685 (plus GST) in satisfaction of the costs orders.

28. As noted above, due to the COVID-19 pandemic the witnesses other than Ms Gluer and Mr Furstenberg appeared via Microsoft Teams and adopted the contents of their affidavits at the hearing. Professor Bennett was the only witness required for cross-examination.

29. The following background is based on the SAFA and SSAFA, the documents annexed to the affidavits of Mr Wooldridge and Ms Gluer and the expert evidence.

    Background

30. In May 2010, the Chiropractic Board of Australia brought disciplinary proceedings against Mr Hooper. The proceedings occupied 66 sitting days before a three-member VCAT Tribunal between January and May 2013. The allegations concerned, amongst other things, advertising on Mr Hooper’s website alleged to be misleading or deceptive. The decision of the Tribunal is reported at Chiropractic Board of Australia v Hooper (Review and Regulation) [2013] VCAT 878 (the VCAT Proceedings).

31. At the time of the VCAT Proceedings Mr Hooper was the sole director of the HyperMED Neurorecovery Australia Clinic (HyperMED) and provided HBOT through that clinic.

32. The VCAT Proceedings concerned a client of HyperMED, QS, who had cerebral palsy. At [11] the Tribunal noted that QS searched the internet and found the site “HyperMED Neurorecovery Australia”. The Tribunal noted at [11] that Mr Hooper informed them that the HyperMED website contained in excess of 900 professional articles as well as commentary and testimonials. At [31] the Tribunal referred to a section of the HyperMED website headed “Conditions Treated”, which gave a long list of conditions under the words “Disorders treatable with Hyperbaric Oxygen Therapy (HBOT)”. The conditions listed included Alzheimer’s disease, autism, diabetes, cerebral palsy and infertility.

33. QS had his first HBOT treatment on 27 August 2007. At [27] the Tribunal noted that by 13 May 2008, QS had completed 269 hours in the HBOT chamber.

34. The Tribunal made findings against Mr Hooper, and a further hearing was held in July 2013 to make a determination pursuant to s 77(4) of the Health Professions Registration Act 2005 (Vic) in relation to the appropriate penalty. The Tribunal’s reasons dated 2 August 2013 are found at Chiropractic Board of Australia v Hooper (Review and Regulation) [2013] VCAT 1346 (the VCAT Penalty Proceedings).

35. In the VCAT Penalty Proceedings, the Tribunal reprimanded Mr Hooper and cancelled his registration as a chiropractor, disqualifying him from applying for re-registration for two years. The Tribunal also ordered that Mr Hooper pay the costs of the Chiropractic Board of Australia.

36. The Tribunal accepted an undertaking proffered by Mr Hooper that he would not provide HBOT treatment in respect of ten conditions, including adult cerebral palsy, infertility and reducing the risk of cancer cell mutation.

37. Mr Hooper also undertook that he would provide the following information to prospective patients and/or their parents or guardians in respect of a list of other conditions, including cerebrovascular stroke, autism, coronary heart disease, hepatitis and multiple sclerosis:

    (a)the provision of HBOT for the condition is novel;

    (b)the consensus of expert medical opinion in Australia and in the scientific literature is that such treatment for the condition is of little or no benefit;

    (c)the provision of such treatment is relatively safe but is not free from risk, including the risk of short term myopia, barotrauma, claustrophobia, fitting in epileptics, pneumothorax (and any other material risk pertaining to the particular patient); and

    (d)the likely treatment cost.

38. At some stage after the VCAT Proceedings, Mr Hooper ceased providing services under the HyperMED Clinic name. Oxymed was registered as a company on 24 June 2015. Mr Hooper was and is its sole director, and continued to provide HBOT services through the Oxymed clinic.  

39. Almost two years prior to the Relevant Period, on 30 May 2018, the TGA’s Advertising Compliance Unit (TGA ACU) sent Oxymed an email attaching a letter dated 29 May 2018 notifying Oxymed that the TGA ACU had received a complaint about Oxymed’s advertising of HBOT devices. The complaint concerned the advertising of HBOT devices despite the HBOT devices no longer being entered on the ARTG. The letter referred to a range of criminal and civil penalty provisions the TG Act relating to advertising, attaching relevant extracts including s 42DLB and parts of the TG Advertising code, as well as a copy of a document entitled “therapeutic goods advertising – compliance and enforcement tools”.

40. On 31 May 2018, Mr Hooper responded to the TGA ACU denying any contravention of the TG Act on the basis that Oxymed did not provide “soft” HBOT and that the “solid steel” HBOT devices featured at Oxymed were registered by Hyperbaric Technologies Australia in 1995. The email also referred to the VCAT Proceedings:

    I gave an undertaking not to treat 10-conditions, which was accepted in the VCAT Final Orders… The VCAT Final Orders, ruled that Dr Hooper was of “good character”, “unyielding in his belief”… The VCAT Final Orders ruled that there were to be “no imposed restrictions” to the “treatable conditions” I have been treating for the past 20+ years using Hyperbaric Oxygen Therapy…

41. On 4 June 2018, the TGA ACU sent an email to Oxymed noting that it had decided to resolve the complaint by sending an educational obligations notice. This was said to “provide you with an opportunity to review your advertising material and to ensure that your advertising is compliant, rather than simply exercising our new regulatory tools noted in the attachment to the notice”. The email included a screenshot from the Website containing an impermissible representation.

42. The 4 June 2018 email concluded by strongly suggesting that Oxymed review its advertising material in detail to ensure compliance with the regulatory framework, noting in particular “the numerous references to restricted and prohibited references and the high-level scientific claims made on the website”; and warning that where matters resurface after the TGA has “taken the time to remind advertisers of their responsibilities it is likely to be considered to represent deliberate non-compliance with the regulatory framework and the TGA will need to consider escalating its response”.

43. There does not appear to have been any further contact between the parties between the 4 June 2018 email and March 2020.

44. On 26 March 2020, the TGA sent Oxymed an “Immediate Notice to Cease and Desist” (the Notice). The Notice, addressed to Mr Hooper, referred to unlawful advertising of the HBOT device on the Website, noting that HBOT devices are not entered on the ARTG or otherwise exempt, approved or authorised under the TG Act. The Notice stated:

    The Therapeutic Goods Administration (TGA) considers that this case is particularly serious due to the representations on the Website concerning a number of diseases that cause considerable fear and anxiety, including HIV AIDS, cancer and COVID-19. Representations concerning such conditions prey on vulnerable people, and can impair the efforts of governments across Australia to address significant public health issues.  The representations made concerning COVID-19 are of significant concern to the TGA and the Australian Government more broadly, given the current pandemic.

1. The Notice warned of potential civil penalties of up to $1.05 million for an individual or $10.5 million for a body corporate. Reference was made to Secretary, Department of Health v Peptide Clinics Australia Pty Ltd [2019] FCA 1107 (Peptides), in which this Court awarded civil penalties totalling $10 million in relation to contraventions of the advertising provisions of the TG Act. I consider the Peptides case in greater detail below.

2. The Notice stated that Oxymed should (emphasis in original):

   [I]mmediately cease advertising the Device on the Website, and cease making representations that HBOT is capable of treating COVID-19, HIV AIDS, cancer and other serious diseases, conditions or disorders.

   [I]mmediately cease advertising the Device, and cease making representations that HBOT is capable of treating COVID-19, HIV AIDS, cancer and other serious diseases, conditions or disorders on any other online platforms connected or associated with Oxymed Australia Pty Ltd, including social media. This should include reviewing [the Facebook Page] and removing any posts or other content that contravenes the Act.

3. The Notice warned that if the Website or other online platforms within Oxymed’s control (including the Facebook Page) continued to advertise the HBOT devices and make the relevant representations after 5pm on 30 March 2020, the TGA would take further steps to prevent, and impose sanctions in relation to, the unlawful advertising. The further steps were said to include commencing legal proceedings.

4. The Notice enclosed five infringement notices addressed to Oxymed and Mr Hooper, in respect of alleged contraventions of subsections 42DLB(2), (4), and (9) of the TG Act on 14 November 2019, 11 March 2020, 20 March 2020 (two contraventions) and 23 March 2020 (together, the Infringement Notices). Each infringement notice imposed a penalty of $12,600. Each infringement notice identified the relevant section of the TG Act that the delegate reasonably believed to have been contravened and provided the details of the alleged contravention. To summarise, the details of the five alleged contraventions were:

   (a)Infringement notice 1: on 20 March 2020, Oxymed contravened s 42DLB(1) (due to the application of subsection (9)) by advertising HBOT devices on the Website in circumstances when the HBOT devices were not entered on the ARTG;

   (b)Infringement notice 2: on 20 March 2020, Oxymed contravened s 42DLB(1) (due to the application of subsection (2)) by making prohibited representations in advertisements on the Website regarding the treatment of cancer;

   (c)Infringement notice 3: on 11 March 2020, Oxymed contravened s 42DLB(1) (due to the application of subsection (4)) by making restricted representations in advertisements on the Website regarding the treatment of COVID-19;

   (d)Infringement notice 4: on 14 November 2019, Oxymed contravened s 42DLB(1) (due to the application of subsection (2)) by making prohibited representations in advertisements on the Website regarding the treatment of PTSD; and

   (e)Infringement notice 5: on 23 March 2020, Oxymed contravened s 42DLB(1) (due to the application of subsection (2)) by making prohibited representations in advertisements on the Website regarding the treatment of HIV AIDS.

5. On 27 March 2020, Mr Wooldridge rang Mr Hooper and confirmed that he had received the Notice and the Infringement Notices.

6. In the afternoon of 27 March 2020, Mr Hooper sent an email to Mr Wooldridge in which he confirmed that he had instructed Oxymed’s web manager to remove content from the Website, including references to the HBOT Device and sections on COVID-19, HIV AIDS, cancer support and PTSD. Mr Hooper also stated that he had “instructed other ‘serious medical conditions’ to be removed, in accordance with your correspondence”.

7. On 3 April 2020, Mr Wooldridge sent an email to Mr Hooper and Oxymed attaching a “Final Notice to Cease and Desist” (Final Notice). The Final Notice appears to have been issued because the contravening representations had not been removed from the Website or Facebook Page. The Final Notice stated (emphasis in original):

   We are providing you with one final opportunity to:

   (a) immediately cease advertising the Device on the Website, and cease making representations that HBOT is capable of treating COVID-19, HIV AIDS, cancer and other serious diseases, conditions or disorders; and

   (b)immediately cease advertising the Device, and cease making representations that HBOT is capable of treating COVID-19, HIV AIDS, cancer and other serious diseases, conditions or disorders on any other online platforms connected or associated with Oxymed Australia Pty Ltd, including social media. This should include reviewing the following Facebook page, and removing posts or other content that contravenes the Therapeutic Goods Act 1989 (the Act).

8. The Final Notice referred to Mr Hooper’s email dated 27 March 2020, and set out the content that Mr Hooper had said would be removed. The Final Notice went on to say:

   Despite your assurances that you have removed the above content from the Website, our review of the Website shows that you have not, in fact, taken down the unlawful content in question from the Website. Unlawful advertisements also continue to be displayed on the Oxymed Facebook page, despite our letter of 26 March 2020 having clearly stated that the relevant material needed to be removed from that page as well. We consider that this failure to take the necessary steps to put an end to your unlawful advertising demonstrates a poor attitude toward compliance with the Act, and needs to be immediately addressed.

9. The Final Notice reiterated that if the Website or other online platforms including the Facebook Page continued to unlawfully advertise after 5pm on 6 April 2020, the TGA would take further steps to prevent, and impose sanctions in relation to, that unlawful advertising.

10. The Final Notice also set out a longer list of the serious diseases, conditions or disorders that were still being advertised on the Website on 31 March 2020 and on the Facebook Page on 1 April 2020 when the TGA conducted a review of both platforms. The Final Notice said that the advertisements “must immediately cease”.

11. On 6 April 2020, Mr Hooper wrote to Mr Woolridge stating that Oxymed had “(hopefully) removed all links and URL’s [sic] from [the Website]”, as well as “all photographs and blogs from the [Facebook Page]”.

12. By 22 April 2020, the Respondents had engaged solicitors, who wrote to the TGA requesting that the Infringement Notices be withdrawn as the material had been taken down. The letter also sought clarification as to the registration status of the HBOT devices, as the Respondents had been assured by the manufacturer, Mr Zeigler of Hyperbaric Technologies Australia, that the HBOT devices were “grandfathered” onto the ARTG.

13. On 23 April 2020, the TGA advised that the request to withdraw the Infringement Notices had been refused, noting “the seriousness of the breaches and the potential harm to public health and safety”.

14. On 24 April 2020, the Respondents’ solicitors wrote to the TGA requesting an extension of time (two months) for the consideration and payment of the Infringement Notices. The solicitors indicated that the Respondents had engaged new legal representatives, so the extension was needed to provide detailed instructions.

15. On 29 April 2020, Mr Hooper himself emailed the TGA requesting leniency in the matter. Mr Hooper also stated that Oxymed had never treated COVID-19 patients, and that the information on the Website “was based on the fact that the site is an educational platform to both medical and allied health care professions on the topic of HBOT” (emphasis in original). He also repeated the claim that the manufacturer of the chambers Mr Zeigler had assured him that the chambers “are conforming and ‘grandfathered’ onto the ARTG list” (emphasis in original).

16. On 1 May 2020 the TGA granted an extension of time for payment of the Infringement Notices to 30 June 2020, noting that Oxymed “must immediately remove all references to restricted and prohibited representations from the website and bring the site into compliance”. Examples of such representations still on the Website included “Post Concussion Symptom – Athletes & Suspected Head Injury” and PTSD.

17. On 6 and 7 May 2020, Mr Hooper sent two further emails to the TGA. The 6 May 2020 email referred to a media release dated 3 May 2020 from the Tasmanian Minister for Health, Sarah Courtney, advising that a new Department of Diving and Hyperbaric Medicine had opened at the Royal Hobart Hospital.  He also stated that “the new Tasmanian chamber is manufactured by Eric Fink, who I have known personally for over 20 years” and provided a link to Fink Engineering’s ARTG registration.

18. The 7 May 2020 email referred to and attached documentation from an upcoming clinical trial on Hyperbaric Oxygen and COVID-19 in the US. After highlighting an extract from the documentation, Mr Hooper stated “this extract from Page 6 of the Clinical Trial submission is exactly what I stated on our website at the time of TGA intervention”.

19. On 21 May 2021 the TGA sent a letter to the Respondents’ solicitor, responding to Mr Hooper’s emails dated 6 and 7 May 2020 and to the extension of time request made on 24 April 2020. The letter stated the following (emphasis in original):

    On 1 May 2020, the delegate considered your request, on behalf of your client, for an extension of 2 months to pay the infringement notices given to Oxymed on 26 March 2020 and decided under subsection 42YKB(2) of the Therapeutic Goods Act 1989 (the Act), to extend the timeframe for payment to 30 June 2020.

    This extension was granted on the basis that Oxymed immediately remove all references to restricted and prohibited representations from the website, and bring the site into compliance. Examples of restricted and prohibited representations on the Oxymed website were provided, including, but not limited to, representations which referred to:

    a. Post Concussion Symptom – Athletes & Suspected Head Injury, being a restricted representation within the meaning of the Act and s 28 of the paragraph 28(1)(a) of the Therapeutic Goods Advertising Code (No.2) 2018 (the Code); and

    b. Post Traumatic Stress Disorder, a prohibited representation within the meaning of the Act and section 30 of the Code.

    Those advertisements continue to be displayed on the Oxymed website, in what the TGA considers a flagrant and deliberate contravention of the Act.

    In addition to the advertising present on the website on 1 May 2020, your client now appears to have added further web content that contains restricted and prohibited representations concerning the use of Hyperbaric Oxygen Therapy Chambers (HBOT). These further representations include, but are not limited to content relating to spinal cord and brain injuries, stroke recovery, cerebral lupus and other serious medical conditions (see, for example, your client’s unlawful advertising continues, in the face of repeated and clear warnings from the TGA and after Oxymed has been given a number of infringement notices in relation to such unlawful advertising, the TGA will be forced to escalate its enforcement response.

    This will include, but is not necessarily limited to, withdrawing the infringement notices and immediately commencing proceedings against Oxymed (and Mr Hooper, as a senior officer of that company) in the Federal Court of Australia seeking pecuniary penalty orders and an urgent interlocutory injunction to bring about the cessation of the unlawful advertising.

    Please confirm by 5pm on 25th May 2020, that your client has removed all references to restricted and prohibited representations from the website and has brought the Website into compliance. If we do not receive that confirmation, or if prohibited and restricted representations continue to be made on your client’s website after that date, the TGA may take further enforcement action without any prior notice to your firm or your client.

    Mr Hooper’s emails of 6 and 7 May 2020

    Mr Hooper has sent the enclosed emails dated 6 and 7 May 2020 to the TGA. Those emails appear to be seeking to argue that Oxymed’s conduct was either lawful, or was not serious in nature, because:

    a) HBOT chambers have been included in the Australian Register of Therapeutic Goods (ARTG) by other persons without providing specific indications (we note that this has no bearing on whether the HBOT chambers used by Oxymed are, in fact, included in the ARTG); and

    b)  a clinical trial submission indicated that a person has theorised that HBOT may be beneficial in treating ‘cytokine storms’, which may arise in the course of the progression of COVID-19.

    Neither of those emails appears to have any substantive relevance to the issues at hand. The content of ARTG entries for other HBOT devices has no bearing on the fact that the HBOT devices advertised by Oxymed were not included in the ARTG, with the result that the relevant advertising contravened the Act.

    Further, the fact that a person has theorised about a potential treatment (presumably to be tested through the clinical trial) for COVID-19 using HBOT is, again, immaterial to the delegate’s decision to give an infringement notice to Oxymed concerning advertising HBOT for COVID-19 related indications. Representations concerning the treatment of COVID-19 are restricted representations. Such representations may not be made in advertisements for therapeutic goods unless a relevant approval or permission is in place, which was not the case here.

    Whether there is a factual basis for the claims made in Oxymed’s advertising (to the extent that a hypothesis advanced in a clinical trial submission could be characterised as reliable clinical evidence, which is questionable) is immaterial to the contravention alleged – regardless of whether the representation is true, making it is unlawful. This prohibition is in place because, as a matter of policy, consumers should receive information about the treatment of serious medical conditions from qualified health practitioners, rather than commercial advertising on the internet or in other locations.

    If your client wishes to request that the notices be withdrawn, it should make a written submission to the delegate for that purpose. That being said, nothing in the correspondence to date would appear to provide any substantive basis for seeking the withdrawal of the notices, and indeed your client’s ongoing non-compliance with the Act would weigh heavily against such a decision.

    If your client does not immediately remove the unlawful advertising from its website, the TGA will take all necessary steps to ensure your client’s non-compliance ceases. As noted above, if your client will not come into compliance based on the action taken to date, the TGA will be forced to take further enforcement action, including obtaining urgent interlocutory relief from the courts.

20. On 25 May 2020 Mr Hooper emailed the TGA, attaching a letter stating that the infringement notices should be withdrawn on the basis that:

    (a)neither he nor Oxymed were the sponsor of HBOT devices used to administer HBOT at the Oxymed clinic;

    (b)the HBOT devices were “grandfathered” onto the ARTG and therefore were entered on the ARTG;

    (c)various content on the Website was of an “educational” nature and therefore did not constitute advertising; and

    (d)the Oxymed clinic had suffered a significant financial downturn since COVID-19.

21. On 23 June 2020 the TGA sent an email and attached letter refusing to withdraw the infringement notices and setting out the reasons for the refusal, noting:

    (a)the TGA accepted that Mr Hooper and Oxymed were not the sponsor of the HBOT devices, nor did they manufacture or import the HBOT devices;

    (b)the HBOT devices were not entered in the ARTG, and the company named by Mr Hooper as having a registration did not have devices of any kind entered on the ARTG. This was clear from searches of the public version of the ARTG on the TGA website;

    (c)the submission that the content on the Website was “educational” was rejected. The Website was said to include a range of content relating to the HBOT services provided at the Oxymed clinic, including pricing information and a “Patient Handbook”. The Website, when viewed as a whole, was clearly intended to promote the use or supply of the devices (by way of administration of HBOT to a patient) and therefore constituted advertising within the meaning of the TG Act;

    (d)the TGA noted that Oxymed could not make any prohibited or restricted representations on the Website unless that representation was subject to a relevant approval or authority. A list of examples of restricted and prohibited representations that had been or continued to be on the Website was included as Annexure A to the letter;

    (e)Annexure A listed 53 diseases or conditions in respect of which restricted representations had been made, including Alzheimer’s disease and COVID-19, and six diseases or conditions the subject of prohibited representations; and

    (f)as to Oxymed’s financial position, the TGA finished by noting that it did not have sufficient financial information to be able to decide whether to withdraw the infringement notices on the basis that the payment of the infringement penalties would cause financial hardship. Oxymed was invited to provide further information in relation to its financial hardship.

    The proceedings

22. The Secretary commenced the proceedings on 20 August 2020.

23. The Website was taken down with no admission as to liability on 21 August 2020. This fact was noted in the orders of Beach J made on 24 August 2020. The orders provided that pending further or other order, the Respondents would not put the Website back online without the prior written consent of the Secretary.

24. The Respondents removed posts from the Facebook Page on 28 September 2020. This was noted in the orders of Beach J made on 28 September 2020.

25. On 18 January 2021, the AGS wrote to Oxymed and Mr Hooper’s lawyers referring to the 24 August 2020 orders and noting that the website was back online without the Secretary’s consent. The website was taken down on 20 January 2021.

26. The SAFA was signed by all parties on 14 April 2021.

27. Schedule A to the SAFA sets out each condition the subject of a restricted representation in the advertisements, and the number of days which the various advertisements remained posted on the Website and Facebook Page. Schedule B does the same for the conditions the subject of prohibited representations. I note that for many of the conditions listed in the Schedules there are two periods given, the first being immediately after the date for cessation given in the Notice (31 March 2020) to early April, and a later period of mid-May or mid-June to mid-August 2020.

28. On 20 April 2021, the AGS wrote to Oxymed and Mr Hooper’s lawyers in relation to content on Mr Hooper’s LinkedIn page. The LinkedIn page was said to contain content similar to that which the Respondents admitted had constituted prohibited and restricted representations in the SAFA. The letter attached screenshots of the LinkedIn page, including links relating to the role of HBOT in treating COVID-19 and aggressive brain tumours. The LinkedIn page described Mr Hooper as “an ‘influencer’, founder and director of OXYMED (formerly HyperMED) where … he gained international renown for providing the wider ‘off-label’ applications of Hyperbaric Oxygenation”; and Mr Hooper’s posts contained links to similar material that had appeared on the Facebook Page and Website.

29. The AGS letter noted the Secretary’s concern that Mr Hooper’s conduct by posting the content on his LinkedIn page “reflects a failure to appreciate his and, by association Oxymed’s, obligations with respect to advertising therapeutic goods”.

1. On 27 April 2021, the Respondents’ lawyers advised that the LinkedIn page had been taken down.

   Oxymed and Mr Hooper

2. Oxymed is an Australian company incorporated in June 2015, with its registered office in Victoria. It has one issued $1 share held by Ms Kate Hooper.

3. Mr Hooper is the sole director and secretary of Oxymed. Mr Hooper was responsible for managing the day-to-day operations of Oxymed during the Relevant Period, including management and oversight of the administration of HBOT to clients, and management and approval of material posted on the Website and Facebook Page.

4. Throughout the Relevant Period, Oxymed carried on a business of administering HBOT via HBOT devices to customers. The cost of HBOT treatment during the Relevant Period was $129.59 per hour.

5. Eighty clients were treated by Oxymed during the Relevant Period. Of those 80 clients, 25 suffered from the conditions set out in Schedules A and B to the SAFA. Oxymed’s turnover during the Relevant Period divided by 80 clients suggests that approximately 2500 hours of HBOT treatments was carried out during that time. However, there was no evidence as to the number of hours each client spent undertaking HBOT treatments during the Relevant Period.

   The Website and the Facebook Page

6. Oxymed promoted the HBOT services through posts on its Website and its Facebook Page. Oxymed operated both the Website and the Facebook Page. Mr Hooper was responsible for all content that was published, and had oversight and authority over what was included or excluded on the Website and Facebook Page.

7. The posts on the Website and Facebook Page include links to many pseudo-scientific articles, testimonials from clients and Mr Hooper’s speaking engagements. The overall impression intended to be imparted to the vulnerable non-scientific reader from the deluge of apparently scientific articles is that HBOT is a credible form of treatment for many diseases and chronic conditions.

8. The hourly cost displayed on the Website screenshots taken during the Relevant Period ranged between $140 to $250, which is described as “reasonable” in comparison to non-hospital HBOT provider costs in the US which are quoted at US$300 to US$450 per session. The Website screenshots also note that “most patients are required to commence HBOT daily” and “[t]ypically most patients with a complex disorder require a ‘saturative baseline’ of between 40–60 and often up to 80–100 hours to ‘commence’ functional changes and stabilisation”.

9. Examples of the material posted on the Website and Facebook Page during the Relevant Period include:

   Coronavirus: Hyperbaric Oxygen Therapy is effective in treating both the primary infection but also the cascading challenges associated with the coronavirus immune response.

   Concussions: Hyperbaric Oxygen Therapy: The battle to help cure concussions “it reduces inflammation in the body and also helps promote the formation of stem cells that can...”

   Cerebral Palsy: Cerebral Palsy & Development delay, near drowning speech delay… Malcolm R Hooper Hyperbaric Oxygen Therapy combined with Robotic Exoskeleton assisted walking for cerebral palsy…

   Multiple sclerosis: OXYMED provides saturative locks of HBOT combined with Australian first LOKOMAT (Robotic Gait Training – Adult and Paediatric) to promote neuroplasticity… OXYMED combination protocols “awakens” dormant neural pathways and provides accurate neurological repetition enhancing and re-training connections and pathways in the brain and spinal cord. Patients have the ability to “salvage back” what has been damaged – the capacity to wake-up dormant pathways, rewire, retrain and reconnect function improving brain and spinal cord function.

   Expert Evidence

10. Professor Bennett and Dr Brownscombe were asked to give their opinion, based on their training, knowledge and experience, as to whether HBOT is a scientifically or clinically accepted treatment for any of the conditions listed in Schedule A to the SAFA. Professor Bennett was also asked to consider the diseases in Schedule B. Professor Bennett and Dr Brownscombe were also instructed to consider whether there were any adverse consequences or risks for patients with any of the Schedule A conditions who pursue HBOT where HBOT is not a scientifically or clinically accepted treatment for that condition.

11. Dr Brownscombe was also asked to prepare a supplementary expert report and provide his opinion as to whether each of the conditions listed in Schedule A was a disease, condition, ailment or defect:

    (a)that is medically accepted to require diagnosis or treatment or supervision by a suitably qualified health professional, except where that form has been medically diagnosed and medically accepted as being suitable for self-treatment and management; or

    (b)for which there is a diagnostic (including screening) preventative, monitoring, susceptibility or pre-disposition test available (including a self-administered test), which requires medical interpretation or follow-up.

12. Dr Brownscombe was also asked to indicate whether, in his opinion, HIV/AIDS, cancer, depression, glioblastoma, mental health and post-traumatic stress disorder, were a form of any of the following:

    (a)neoplastic disease;

    (b)sexually transmitted diseases;

    (c)HIV/AIDS;

    (d)hepatitis C virus; or

    (e)mental illness.

    The SAFA conditions

13. In the expert opinion of Dr Brownscombe, each of the 49 conditions listed in Schedule A were conditions which are medically accepted to require diagnosis, treatment, or supervision by a suitably qualified health professional. In respect of three of the listed conditions (back pain, burns and irritable bowel syndrome) Dr Brownscombe qualified his response by noting that mild variants may not require medical diagnosis or treatment.

14. Dr Brownscombe’s evidence was that HBOT was a first line treatment for decompression sickness. Additionally, Dr Brownscombe gave evidence that HBOT is an “adjunctive” treatment (that is, it supports the main treatment) for a number of further conditions including carbon monoxide poisoning, necrotising soft tissue infections, and idiopathic sudden sensorineural hearing loss.

15. Professor Bennett’s evidence was that four of the conditions in the list shown to him (carbon monoxide poisoning, hearing loss, sensorineural hearing loss and radiation necrosis) were “widely accepted as appropriate for the routine application of HBOT”.

16. In Professor Bennett’s opinion, the clinical evidence strongly supported the assertion that HBOT is not warranted in the treatment of multiple sclerosis, cerebral palsy and autism spectrum disorders. For the remaining conditions, including those in Schedule B, his opinion was that HBOT was not a scientifically and clinically accepted treatment. Professor Bennett noted that high quality evidence in support of the routine use of HBOT required randomised controlled trials or systematic reviews of such trials, and such randomised controlled trials of HBOT are difficult as there is a substantial placebo effect.

17. Professor Bennett’s report referred to an article he had co-authored entitled “Unestablished indications for hyperbaric oxygen therapy” in which he wrote:

    Hyperbaric oxygen treatment (HBOT) is a therapeutic modality that has long struggled for credibility within “mainstream” medicine.  In large part this has been due to a lack of high-quality evidence to support HBOT in its various indications.

18. For conditions where there is a known benefit to providing HBOT, HBOT is provided in a hospital based facility. There is at least one hospital HBOT facility in each state in Australia, and two in some states.

    Effects of HBOT

19. Dr Brownscombe gave evidence as to the effects on the human body of breathing 100% oxygen at increased atmospheric pressure (HBOT is intended to deliver oxygen at 100% concentration and at a pressure above atmospheric pressure and is administered using HBOT devices). Dr Brownscombe identified two main effects. First, the increased pressure reduces the volume of gas-filled spaces, forming the basis for treatment of decompression sickness and air embolism. Second, an increased amount of oxygen dissolves in the bloodstream, meaning more oxygen is delivered to the body’s organs and tissues, forming the basis for treatment of conditions where impaired oxygen-carrying capacity is evident, such as carbon monoxide poisoning and severe anaemia, and where improved blood supply can improve tissue healing, such as ulcers.

20. While Professor Bennett agreed that HBOT is relatively benign when compared to many medical interventions, he noted that there was the potential for financial and physical harm to patients. An inflated belief of expected benefit from HBOT may have consequences for patients and their families. As Professor Bennett noted in his article “desperate patients with chronic or progressive problems are frequently willing to ‘try anything’, and it is not difficult to convince such patients to try HBOT”. In choosing the “unproven” HBOT a patient may be prevented from using alternative, more effective therapies or treatments.  Not only is there the loss of opportunity for the best possible treatment, there is also a financial burden to the patient in paying for the HBOT.

21. Dr Brownscombe also gave evidence as to the potential risk to patients from pursuing HBOT at the expense of pursuing established treatment for their conditions, which could lead to their conditions worsening, or in some conditions even death. Dr Brownscombe agreed that another form of potential harm to HBOT patients was financial harm from the cost of HBOT treatment.

    THE CONTRAVENING CONDUCT

22. Oxymed and Mr Hooper admitted (and the expert evidence establishes) the contraventions of s 42DLB(1) of the TG Act during the Relevant Period alleged by the Secretary.

23. Oxymed and Mr Hooper admitted that Mr Hooper aided, abetted, counselled or procured Oxymed’s contraventions of s 42DLB(1) and was therefore involved in those contraventions for the purposes of s 42YC of the TG Act.

    Advertising goods not listed in the ARTG

24. Oxymed and Mr Hooper admit (consistently with Dr Brownscombe’s evidence) that:

    (a)the HBOT devices are therapeutic goods within the meaning of s 3 of the TG Act;

    (b)the HBOT devices are not, and were not during the Relevant Period, entered in the ARTG maintained by the Secretary pursuant to s 9A(1) of the TG Act; and

    (c)the HBOT devices are not, and were not at any relevant time, the subject of an exemption, approval or authority under the TG Act or TG Regulations.

25. Following on from the above, Mr Hooper and Oxymed admit that the HBOT devices are, and were at all relevant times throughout the Relevant Period, prescribed by regulation 7(i) of the TG Regulations for the purpose of s 42DLB(9).

26. As noted above, there was some evidence as to Mr Hooper’s previously-held mistaken belief that the HBOT devices were “grandfathered” on to the ARTG.

27. The Respondents admit that throughout the Relevant Period they advertised or caused the HBOT devices to be advertised on the Website and Facebook Page, including by:

    (a)making statements on the Website and Facebook Page to promote the use of the HBOT devices, by participating in HBOT in the Oxymed Clinic;

    (b)publishing pictorial representations of the HBOT devices on the Website and Facebook Page when promoting HBOT services offered at the Oxymed clinic;

    (c)offering HBOT services at the Oxymed clinic and a price list for such services on the Website; and

    (d)promoting the health benefits of the HBOT treatment in conjunction with the treatment or cure of a variety of conditions and illnesses, including those listed at Schedules A and B of the SAFA.

28. Mr Wooldridge annexed to his affidavits screenshots of posts on the Website and Facebook Page taken during the Relevant Period. Dr Brownscombe was shown some of the screenshots and identified the devices as being hyperbaric oxygen chambers which he said were intended to deliver oxygen at 100% concentration and at increased (above atmospheric) pressure.

29. A number of the screenshots make indirect references to HBOT devices by virtue of selling HBOT services, namely the delivery of oxygen at 100% concentration and at increased pressure from HBOT devices, promoted in conjunction with the treatment or cure of certain conditions. For example one screenshot regarding COVID-19 states “Hyperbaric Oxygen Therapy is effective in treating both the primary infection but also the cascading challenges associated with the coronavirus immune response”. Another screenshot describing a study regarding treatment for fatigue associated with HIV/AIDS states “Patients were treated with 100% oxygen at two atmospheres of absolute pressure three times per week for two months… It was concluded that hyperbaric oxygen therapy is an effective adjunctive treatment in the medical management of HIV/AIDS”.

    Restricted Representations

30. The Website and Facebook Page screenshots contain representations relating to each of the 49 conditions listed in Schedule A of the SAFA and the five conditions listed in Schedule B.

31. The Secretary’s submissions set out examples of the advertisements taken from the screenshots of the Website and Facebook Page captured by Mr Wooldridge and alleged to contain restricted representations:

    Coronavirus: “Hyperbaric Oxygen Therapy is effective in treating both the primary infection but also the cascading challenges associated with the coronavirus immune response.”

    Concussions: “Hyperbaric Oxygen Therapy: The battle to help cure concussions “it reduces inflammation in the body and also helps promote the formation of stem cells that can...”

    Cerebral Palsy: “Cerebral Palsy & Development delay, near drowning, speech delay... Malcolm R Hooper Hyperbaric Oxygen Therapy combined with Robotic Exoskeleton assisted walking for cerebral palsy...” and under the heading “WORLD leading experts” “Dr Arun Mukherjee...HBOT has shown to have positive therapeutic effects on children with cerebral palsy in many clinical trials. However, there is still controversy and resistance to the recognition of cerebral palsy as an indication for HBOT... the eight month long benefits we have observed with combined treatments versus rehabilitation can only have been due to a beneficial effect of hyperbaric treatment.”

    Multiple sclerosis: “OXYMED provides saturative locks of HBOT combined with Australian first LOKOMAT (Robotic Gait Training- Adult and Paediatric) to promote neuroplasticity...OXYMED combination protocols ‘awakens’ dormant neural pathways and provides accurate neurological repetition enhancing and re-training connections and pathways in the brain and spinal cord. Patients have the ability to ‘salvage back’ what has been damaged – the capacity to wake-up dormant pathways, rewire, retrain and reconnect function improving brain and spinal cord function.”

32. The Respondents admit (consistently with Dr Brownscombe’s unchallenged expert evidence) that each of the conditions listed in Schedule A is a “serious form” of a disease, condition, ailment or defect within the meaning of ss 42DD and 42DLB(4) of the TG Act. Therefore, each of the representations that contained reference to any of the 49 conditions listed in Schedule A are “restricted representations” within the meaning of s 28 of the TG Advertising Code.

33. The Respondents admit that, during the Relevant Period from at least 11 March 2020, they advertised or caused to be advertised the HBOT devices in circumstances where those advertisements contained restricted representations. The Respondents further admit that they did not have approval from the Secretary under s 42DF(1) of the TG Act, or permission under s 42DK(1) to make the restricted representations on the Website or Facebook Page.

    Prohibited representations

34. Mr Wooldridge’s evidence included screenshots from the Website and Facebook Page containing references to the use of HBOT devices in conjunction with HBOT, to assist in the treatment of cancer, AIDS/HIV and mental illness.

35. Examples of the advertisements taken from the screenshots of the Website and Facebook Page captured by Mr Wooldridge and alleged to contain prohibited representations were set out in the Secretary’s submissions:

    Cancer: “Integrative cancer support. Hyperbaric oxygen is an immune modulation therapy...HBOT may increase the amount of oxygen in cancer cells, which may make them easier to kill with radiation therapy and chemotherapy. HBOT is a type of radiosensitizing agent and a type of chemosensitizing agent...HBOT assists immune responses to chemotherapy reducing immunosuppression and neutropenia.”

    AIDS/HIV: “to establish HBOT as an adjunctive care for children & adults suffering the effect of AIDS. It is our vision that mobile shipping containers housing small multiplace chambers can be specifically located via truck or helicopter into remote regions to assist communities impacted by the devastating effects of AIDS.”

    Depression: “Depression – Oxymed Hyperbaric Oxygen Therapy Tier... (quoting an article) “conclusions: our results suggest that HBOT may ameliorate Traumatic Brain Injury (TBI)-induced depression-like behaviour in rats by attenuating neuroinflammation, representing one possible mechanism by which depression-like behaviour recovery might occur. We also recommend HBO as a potential treatment for TBI-induced depression-like behaviour if early intervention is possible”

    Post-traumatic stress disorder: (quoting an article) “Hyperbaric Oxygen ameliorates worsening signs and symptoms of post-traumatic stress disorder… We propose that hyperbaric oxygen was effective in improving the patient’s neuropsychiatric symptoms by reducing cerebral oxidative stress, inflammation, vasogenic edema, and hippocampal neuronal apoptosis.”

36. Each of HIV/AIDS, neoplastic disease (cancer) and mental illness (depression and post-traumatic stress disorder) are conditions which are expressly listed in s 30 of the TG Advertising Code and as such the representations which refer to them fall within the meaning of prohibited representations for the purposes of s 42DLB(2) of the TG Act.

37. At no time during the Relevant Period did Oxymed or Mr Hooper have permission from the Secretary to make prohibited representations on the Website or Facebook Page. No exemptions under s 42AA of the Act apply to the conduct of Oxymed and Mr Hooper.

38. The Respondents admit that they advertised the HBOT devices, or caused the HBOT devices to be advertised in circumstances where those advertisements contained references to prohibited representations within the meaning of s 30 of the TG Advertising Code for the purpose of r 6B(1)(b) of the TG Regulations and therefore within the meaning of s 42DJ(1) of the TG Act.

39. Although Oxymed and Mr Hooper submit that the Website was for “educational purposes”, it was available to the general public without restriction. It was not directed exclusively to medical practitioners, persons engaged in the business of wholesaling therapeutic goods, naturopaths, and other homeopathic practitioners, or advice or information directly provided to a patient from a medical practitioner.

    APPLICABLE PRINCIPLES

40. The general principles applicable to pecuniary penalties were not in dispute.

41. The principal object of a civil penalty is deterrence: both specific deterrence of repetition of the conduct by the contravener and, by their example, general deterrence of other would-be contraveners: Australian Building and Construction Commissioner v Construction, Forestry, Mining and Energy Union (2018) 262 CLR 157 at [116] (Keane, Nettle and Gordon JJ).

42. The penalty should not be oppressive, in the sense that it should be no higher than necessary to achieve the object of deterrence: Australian Competition and Consumer Commission v Leahy Petroleum Pty Ltd (No 2) (2005) 215 ALR 281 at [9]. However, the amount must be fixed with a view to ensuring that the penalty is not such as to be regarded by the contravener or others as an acceptable cost of doing business: Singtel Optus Pty Ltd v Australian Competition and Consumer Commission (2012) 287 ALR 249 at [62].

1. The Secretary also seeks an order that Oxymed and Mr Hooper pay the Secretary’s costs of and incidental to the proceedings. I consider that such an order is appropriate.

I certify that the preceding two hundred and seventy-six (276) numbered paragraphs are a true copy of the Reasons for Judgment of the Honourable Justice Rofe.

Associate:

Dated:       3 December 2021

ANNEXURE A – STATEMENT OF AGREED FACTS AND ADMISSIONS

STATEMENT OF AGREED FACTS AND ADMISSIONS

FEDERAL COURT OF AUSTRALIA
DISTRICT REGISTRY: VICTORIA
DIVISION: GENERAL  NO VID 558 OF 2020

SECRETARY OF THE DEPARTMENT OF HEALTH
Applicant

OXYMED AUSTRALIA PTY LTD (ACN 606 641 954) and another named in the schedule
Respondents

A      INTRODUCTION

1.This Statement of Agreed Facts and Submissions (SAFA) is made for the purposes of s 191 of the Evidence Act 1995 (Cth) jointly by the Applicant and the Respondents.

2.This SAFA relates to proceedings VID 558/2020 commenced by the Applicant (Secretary) against the Respondents by way of Originating Application and Affidavit filed on 21 August 2020 (Proceedings).

3.In the Proceedings, the Secretary seeks the relief set out in the Originating Application dated 21 August 2020, comprising:

3.1.declarations pursuant to s 21 of the Federal Court of Australia Act 1976 (Cth) (FCAA);

3.2.injunctions pursuant to s 42YN of the Therapeutic Goods Act 1989 (Cth) (TG Act); and

3.3.pecuniary penalties pursuant to s 42Y of the TG Act; and costs.

4.This SAFA identifies facts relevant to the contraventions of s 42DLB(1) of the TG Act that occurred between at least 20 February 2020 to 17 August 2020 (Relevant Period), which contraventions are admitted by the Respondents for the purposes of the Proceedings.

B      THE PARTIES

5.The Secretary may apply to the Court for a declaration of contravention, injunction and a pecuniary penalty order pursuant to s 21 of the FCAA, s 42YN and s 42Y of the TG Act.

6.Throughout the Relevant Period, Oxymed Australia Pty Ltd (Oxymed):

6.1.was incorporated pursuant to the Corporations Act 2001 (Cth);

6.2.had its registered office in Victoria, Australia; and

6.3.carried on a business of administering hyperbaric oxygen therapy (HBOT) via hyperbaric oxygen therapy chambers (HBOT devices) to customers and promoting the HBOT services through advertisements on its website located at (the Website) and its Facebook page located at facebook.com/oxymedaustralia (Facebook Page).

7.Mr Malcolm Hooper (Mr Hooper) is the sole director and secretary of Oxymed.

8.In his capacity as sole director of Oxymed, Mr Hooper was responsible for managing the day-to-day operations of the company during the Relevant Period, including:

8.1.management and oversight of the administration of HBOT to clients;

8.2.management and approval of advertising and promotional materials published on the Website; and

8.3.management and approval of advertising and promotional materials published on the Facebook Page.

C      THE CONDUCT

Oxymed Website and Facebook Page

9.Throughout the Relevant Period:

9.1.Oxymed operated the Website.

9.2.Mr Hooper was the registered contact for the Website.

9.3.Oxymed operated the Facebook Page.

9.4.Mr Hooper was responsible for all content that was published on the Website and Facebook Page and had oversight and authority over what was included or excluded from the Website and Facebook Page.

Hyperbaric Oxygen Therapy and Hyperbaric Oxygen Therapy Devices

10.HBOT is administered using HBOT devices.

11.HBOT is intended to deliver oxygen at 100% concentration and at a pressure above atmospheric pressure.

12.The HBOT devices are therapeutic goods within the meaning of s 3(1) of the TG Act because they are represented in a way to be, or are likely to be taken to be, for therapeutic use, namely for use in, or in connection with:

12.1.preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or

12.2.influencing, inhibiting or modifying a physiological process in persons; or

12.3.testing the susceptibility of persons to a disease or ailment.

Advertisements referring to the HBOT Devices

13.Throughout the Relevant Period, Oxymed advertised or caused the HBOT devices to be advertised on the Website and the Facebook Page within the meaning of s 3(1) of the TG Act, by promoting the use or supply of the HBOT devices as therapeutic goods for therapeutic use, including by:

13.1.making statements on the Website and Facebook Page to promote the use of the HBOT devices, by participating in HBOT, in the Oxymed clinic;

13.2.publishing pictorial representations of the HBOT devices on the Website and Facebook page when promoting the HBOT services offered at the Oxymed clinic;

13.3.offering HBOT services at the Oxymed clinic and a price list for such services; and

13.4.promoting the health benefits of the HBOT treatment in conjunction with the treatment or cure of a variety of conditions and illnesses, included those listed at Schedules A and B.

14.The HBOT devices are not, and were not at any relevant time, entered in the Australian Register of Therapeutic Goods maintained by the Secretary pursuant to s 9A(1) of the TG Act.

15.The HBOT devices are not, and were not at any relevant time, the subject of an exemption, approval or authority under the TG Act, nor an exemption, approval or authority under regulations made under the TG Act.

16.Consequently, the HBOT devices are, and were at all relevant times throughout the Relevant Period, prescribed by reg 7(i) of the Therapeutic Goods Regulations 1990 (Cth) (TG Regulations) for the purposes of s 42DLB(9) of the TG Act.

17.Mr Hooper knew each of the matters set out in paragraphs 13 to 15 above, and caused or permitted the conduct of Oxymed referred to in paragraph 13 above by virtue of the matters set out in paragraphs 7, 8 and 9.4 above.

Advertisements containing restricted representations

18.During the Relevant Period, from at least 11 March 2020, Oxymed advertised the HBOT devices, or caused the HBOT devices to be advertised in circumstances where those advertisements contained references to the diseases or conditions or ailments listed in Schedule A.

19.The diseases or conditions or ailments, referred to in Schedule A were each serious forms of those diseases, conditions or ailments, within the meaning of s 28 of the Therapeutic Goods Advertising Code (No 2) 2018 (Cth) (TG Code), since it is medically accepted that they require diagnosis or treatment or supervision by a suitably qualified health professional, except where they have been medically diagnosed and medically accepted as being suitable for self-treatment and management.

20.The advertisements referred to in paragraph 18 above constituted representations, which were restricted representations within the meaning of s 42DD of the TG Act.

21.At no time did the Secretary give an approval under s 42DF(1) of the TG Act, or permission under s 42DK(1) of the TG Act, to make the restricted representations.

22.Mr Hooper knew of each of the matters alleged in paragraphs 18 and 21 above, and caused or permitted the conduct of Oxymed alleged in paragraph 18 above by virtue of the matters set out in paragraphs 7, 8 and 9.4 above.

Advertisements containing prohibited representations

23.During the Relevant Period, from at least 20 February 2020 to 19 June 2020, Oxymed advertised the HBOT Devices, or caused the HBOT Devices to be advertised in circumstances where those advertisements contained references to the diseases, or conditions or ailments listed in Schedule B.

24.The advertisements referred to in paragraph 23 above constituted representations, which were prohibited representations under s 30 of the TG Code for the purposes of reg 6B(1)(b) of the TG Regulations and, therefore, within the meaning of s 42DJ(1) of the TG Act.

25.At no time was a permission in force under s 42DK(1) of the TG Act in relation to the prohibited representations.

26.Mr Hooper knew of each of the matters alleged in paragraphs 23 and 25 above, and caused or permitted the conduct of Oxymed referred to in paragraph 23 above by virtue of the matters set out in paragraphs 7, 8 and 9.4 above.

D      ADMITTED CONTRAVENTIONS

27.The Respondents admit that, during the Relevant Period:

28.By the conduct described in paragraphs 13 and 17 above, Oxymed and Mr Hooper each contravened s 42DLB(1) of the TG Act since s 42DLB(9) applies. .

29.By the conduct described in paragraphs 18 and 22 above, Oxymed and Mr Hooper each contravened s 42DLB(1) of the TG Act since s 42DLB(4) applies.

30.By the conduct described in paragraphs 23 and 26 above, Oxymed and Mr Hooper each contravened s 42DLB(1) of the TG Act since s 42DLB(2) applies.

31.Further to paragraphs 27 to 30 above, by reason of the matters alleged in paragraphs 7, 8, 9.4, 17, 22 and 26 above, Mr Hooper aided, abetted, counselled or procured Oxymed’s contraventions of s 42DLB(1) and was therefore involved in those contraventions for the purposes of s 42YC of the TG Act.

Date: 14 April 2021

........ ........ ........ ........ ........ .

Matthew Garey

AGS lawyer

Lawyer for the Applicant

Date: 14 April 2021

........ ........ ........ ........ ........ ......

Lawyer for the First Respondent

Date: 14 April 2021

........ ........ ........ ........ ........ ....

Lawyer for the Second
Respondent

Schedule

FEDERAL COURT OF AUSTRALIA
DISTRICT REGISTRY: VICTORIA
DIVISION: GENERAL  NO VID 558 OF 2020

SECRETARY OF THE DEPARTMENT OF HEALTH
Applicant

OXYMED AUSTRALIA PTY LTD (ACN 606 641 954)
First Respondent
MALCOLM HOOPER
Second Respondent

Date: 14 April 2021

SCHEDULE A

Condition	Date of Representations	Date of Screenshot	Exhibit IJW-1 Reference
Alzheimer's disease	31/03/2020-2/04/2020; 14/05/2020-17/08/2020	31/03/2020	Volume 1, Tab 34, Page 344
		2/04/2020	Volume 1, Tab 35, Page 456
		14/05/2020	Volume 2, Tab 42, Page 638
		20/05/2020	Volume 2, Tab 46, Page 716
		4/06/2020	Volume 3, Tab 70, Page 1389
		4/06/2020	Volume 3, Tab 70, Page 1392
		17/06/2020	Volume 2, Tab 54, Page 849
		17/06/2020	Volume 2, Tab 54, Page 865
		17/06/2020	Volume 2, Tab 54, Page 883
		18/06/2020	Volume 3, Tab 60, Page 1170
		7/07/2020	Volume 3, Tab 65, Page 1251
		24/07/2020	Volume 3, Tab 66, Page 1283
		24/07/2020	Volume 3, Tab 66, Page 1299
		24/07/2020	Volume 3, Tab 66, Page 1300
		17/08/2020	Volume 3, Tab 72, Page 1424
		17/08/2020	Volume 3, Tab 72, Page 1425
		17/08/2020	Volume 3, Tab 72, Page 1439
Amyotrophic Lateral Sclerosis	31/03/2020-2/04/2020;	31/03/2020	Volume 1, Tab 34, Page 344
		2/04/2020	Volume 1, Tab 35, Page 396
		2/04/2020	Volume 1, Tab 35, Page 497
Autism Spectrum Disorders	31/03/2020-2/04/2020; 14/05/2020-18/06/2020; 24/07/2020	31/03/2020	Volume 1, Tab 34, Page 344
		2/04/2020	Volume 1, Tab 35, Page 420
		2/04/2020	Volume 1, Tab 35, Page 432
		14/05/2020	Volume 2, Tab 42, Page 625
		20/05/2020	Volume 2, Tab 46, Page 703
		20/05/2020	Volume 2, Tab 46, Page 716
		20/05/2020	Volume 2, Tab 46, Page 722
		21/05/2020	Volume 3, Tab 69, Page 1356
		28/05/2020	Volume 2, Tab 50, Page 784
		28/05/2020	Volume 2, Tab 50, Page 786
		4/06/2020	Volume 3, Tab 70, Page 1377
		4/06/2020	Volume 3, Tab 70, Page 1388
		17/06/2020	Volume 2, Tab 54, Page 849
		17/06/2020	Volume 2, Tab 54, Page 865
		17/06/2020	Volume 2, Tab 54, Page 875
		17/06/2020	Volume 2, Tab 54, Page 876
		17/06/2020	Volume 2, Tab 54, Page 883
		17/06/2020	Volume 2, Tab 54, Page 884
		17/06/2020	Volume 2, Tab 57, Page 1115
		17/06/2020	Volume 2, Tab 58, Page 1139
		18/06/2020	Volume 3, Tab 60, Page 1170
		18/06/2020	Volume 3, Tab 61, Page 1176
		24/07/2020	Volume 3, Tab 66, Page 1285
Autoimmune Illness	31/03/2020-2/04/2020; 14/05/2020	31/03/2020	Volume 1, Tab 34, Page 339
		31/03/2020	Volume 1, Tab 34, Page 344
		31/03/2020	Volume 1, Tab 34, Page 368
		2/04/2020	Volume 1, Tab 35, Page 438
		14/05/2020	Volume 2, Tab 42, Page 642
Back Pain	13/03/2020-2/04/2020	13/03/2020	Volume 1, Tab 27, Page 308
		31/03/2020	Volume 1, Tab 34, Page 364
		2/04/2020	Volume 1, Tab 35, Page 399
		2/04/2020	Volume 1, Tab 35, Page 402
Brain Injury	13/03/2020-3/04/2020; 27/04/2020-24/07/2020	13/03/2020	Volume 1, Tab 27, Page 310
		31/03/2020	Volume 1, Tab 34, Page 344
		31/03/2020	Volume 1, Tab 34, Page 345
		2/04/2020	Volume 1, Tab 35, Page 398
		3/04/2020	Volume 2, Tab 36, Page 594
		27/04/2020	Volume 2, Tab 39, Page 608
		14/05/2020	Volume 2, Tab 41, Page 614
		14/05/2020	Volume 2, Tab 42, Page 616
		14/05/2020	Volume 2, Tab 42, Page 618
		14/05/2020	Volume 2, Tab 42, Page 631
		14/05/2020	Volume 2, Tab 42, Page 632
		14/05/2020	Volume 2, Tab 42, Page 638
		14/05/2020	Volume 2, Tab 43, Page 679
		20/05/2020	Volume 2, Tab 45, Page 691
		20/05/2020	Volume 2, Tab 45, Page 693
		20/05/2020	Volume 2, Tab 46, Page 701
		20/05/2020	Volume 2, Tab 46, Page 709
		20/05/2020	Volume 2, Tab 46, Page 723
		21/05/2020	Volume 3, Tab 68, Page 1319
		21/05/2020	Volume 3, Tab 69, Page 1356
		21/05/2020	Volume 3, Tab 69, Page 1361
		28/05/2020	Volume 2, Tab 50, Page 784
		28/05/2020	Volume 2, Tab 50, Page 789
		29/05/2020	Volume 2, Tab 52, Page 820
		4/06/2020	Volume 3, Tab 70, Page 1377
		4/06/2020	Volume 3, Tab 70, Page 1379
		17/06/2020	Volume 2, Tab 54, Page 849
		17/06/2020	Volume 2, Tab 54, Page 859
		17/06/2020	Volume 2, Tab 54, Page 886
		17/06/2020	Volume 2, Tab 58, Page 1136
		17/06/2020	Volume 2, Tab 58, Page 1139
		18/06/2020	Volume 3, Tab 61, Page 1174
		18/06/2020	Volume 3, Tab 61, Page 1176
		18/06/2020	Volume 3, Tab 61, Page 1178
		24/07/2020	Volume 3, Tab 66, Page 1286
		24/07/2020	Volume 3, Tab 66, Page 1289
Carbon monoxide (CO) poisoning	13/03/2020-3/04/2020; 21/05/2020-29/05/2020; 17/06/2020	13/03/2020	Volume 1, Tab 29, Page 316
		31/03/2020	Volume 1, Tab 34, Page 344
		31/03/2020	Volume 1, Tab 34, Page 345
		2/04/2020	Volume 1, Tab 35, Page 418
		3/04/2020	Volume 2, Tab 36, Page 597
		21/05/2020	Volume 3, Tab 69, Page 1356
		21/05/2020	Volume 3, Tab 69, Page 1360
		29/05/2020	Volume 2, Tab 52, Page 804
		17/06/2020	Volume 2, Tab 54, Page 875
		17/06/2020	Volume 2, Tab 54, Page 876
		17/06/2020	Volume 2, Tab 54, Page 877
		17/06/2020	Volume 2, Tab 57, Page 1115
		17/06/2020	Volume 2, Tab 57, Page 1119
		17/06/2020	Volume 2, Tab 58, Page 1139
Cellulitis	31/03/2020	31/03/2020	Volume 1, Tab 34, Page 344
Cerebral Malaria	31/03/2020	31/03/2020	Volume 1, Tab 34, Page 344
Cerebral Palsy	31/03/2020-2/04/2020; 14/05/2020-7/07/2020	31/03/2020	Volume 1, Tab 34, Page 344
		31/03/2020	Volume 1, Tab 34, Page 345
		2/04/2020	Volume 1, Tab 35, Page 449
		2/04/2020	Volume 1, Tab 35, Page 396
		2/04/2020	Volume 1, Tab 35, Page 398
		2/04/2020	Volume 1, Tab 35, Page 420
		2/04/2020	Volume 1, Tab 35, Page 422
		2/04/2020	Volume 1, Tab 35, Page 486
		2/04/2020	Volume 1, Tab 35, Page 538
		14/05/2020	Volume 2, Tab 41, Page 616
		14/05/2020	Volume 2, Tab 42, Page 625
		14/05/2020	Volume 2, Tab 42, Page 638
		14/05/2020	Volume 2, Tab 42, Page 643
		14/05/2020	Volume 2, Tab 42, Page 645
		14/05/2020	Volume 2, Tab 42, Page 647
		14/05/2020	Volume 2, Tab 42, Page 648
		14/05/2020	Volume 2, Tab 42, Page 660
		20/05/2020	Volume 2, Tab 45, Page 693
		20/05/2020	Volume 2, Tab 46, Page 703
		20/05/2020	Volume 2, Tab 46, Page 716
		20/05/2020	Volume 2, Tab 46, Page 721
		20/05/2020	Volume 2, Tab 46, Page 724
		20/05/2020	Volume 2, Tab 46, Page 725
		20/05/2020	Volume 2, Tab 46, Page 726
		20/05/2020	Volume 2, Tab 46, Page 738
		21/05/2020	Volume 3, Tab 69, Page 1356
		21/05/2020	Volume 3, Tab 69, Page 1362
		28/05/2020	Volume 2, Tab 50, Page 784
		28/05/2020	Volume 2, Tab 50, Page 789
		29/05/2020	Volume 2, Tab 52, Page 822
		29/05/2020	Volume 2, Tab 52, Page 805
		4/06/2020	Volume 3, Tab 70, Page 1391
		17/06/2020	Volume 2, Tab 54, Page 849
		17/06/2020	Volume 2, Tab 54, Page 863
		17/06/2020	Volume 2, Tab 54, Page 867
		17/06/2020	Volume 2, Tab 54, Page 875
		17/06/2020	Volume 2, Tab 54, Page 876
		17/06/2020	Volume 2, Tab 54, Page 877
		17/06/2020	Volume 2, Tab 54, Page 883
		17/06/2020	Volume 2, Tab 56, Page 986
		17/06/2020	Volume 2, Tab 56, Page 993
		17/06/2020	Volume 2, Tab 57, Page 1115
		17/06/2020	Volume 2, Tab 57, Page 1121
		17/06/2020	Volume 2, Tab 58, Page 1139
		17/06/2020	Volume 2, Tab 58, Page 1149
		17/06/2020	Volume 2, Tab 54, Page 889
		18/06/2020	Volume 3, Tab 60, Page 1170
		24/07/2020	Volume 3, Tab 66, Page 1283
		7/07/2020	Volume 3, Tab 65, Page 1252
Near Drowning (submersion injuries)	31/03/2020-2/04/2020; 14/05/2020-17/06/2020	31/03/2020	Volume 1, Tab 34, Page 344
		2/04/2020	Volume 1, Tab 35, Page 396
		2/04/2020	Volume 1, Tab 35, Page 411
		2/04/2020	Volume 1, Tab 35, Page 420
		14/05/2020	Volume 2, Tab 42, Page 643
		29/05/2020	Volume 2, Tab 52, Page 820
		29/05/2020	Volume 2, Tab 52, Page 825
		4/06/2020	Volume 3, Tab 70, Page 1381
		17/06/2020	Volume 2, Tab 54, Page 859
		17/06/2020	Volume 2, Tab 54, Page 860
Chronic Fatigue Illness	31/03/2020-2/04/2020	31/03/2020	Volume 1, Tab 34, Page 344
		2/04/2020	Volume 1, Tab 35, Page 396
		2/04/2020	Volume 1, Tab 35, Page 425
Chronic Infections	31/03/2020-2/04/2020	31/03/2020	Volume 1, Tab 34, Page 344
		31/03/2020	Volume 1, Tab 34, Page 368
		2/04/2020	Volume 1, Tab 35, Page 396
		2/04/2020	Volume 2, Tab 43, Page 676
Complex Pain Syndrome	31/03/2020-2/04/2020	31/03/2020	Volume 1, Tab 34, Page 344
		2/04/2020	Volume 1, Tab 35, Page 396
Concussion Disability	13/03/2020-2/04/2020; 14/05/2020-29/06/2020	13/03/2020	Volume 1, Tab 27, Page 309
		31/03/2020	Volume 1, Tab 34, Page 344
		31/03/2020	Volume 1, Tab 34, Page 345
		2/04/2020	Volume 1, Tab 35, Page 396
		2/04/2020	Volume 1, Tab 35, Page 570
		2/04/2020	Volume 1, Tab 35, Page 588
		14/05/2020	Volume 2, Tab 42, Page 624
		14/05/2020	Volume 2, Tab 44, Page 686
		20/05/2020	Volume 2, Tab 46, Page 702
		20/05/2020	Volume 2, Tab 46, Page 714
		20/05/2020	Volume 2, Tab 48, Page 771
		21/05/2020	Volume 3, Tab 68, Page 1323
		21/05/2020	Volume 3, Tab 69, Page 1356
		21/05/2020	Volume 3, Tab 69, Page 1361
		28/05/2020	Volume 2, Tab 50, Page 788
		29/05/2020	Volume 2, Tab 51, Page 793
		4/06/2020	Volume 3, Tab 70, Page 1366
		17/06/2020	Volume 2, Tab 54, Page 877
		17/06/2020	Volume 2, Tab 54, Page 883
		17/06/2020	Volume 2, Tab 54, Page 884
		17/06/2020	Volume 2, Tab 54, Page 886
		17/06/2020	Volume 2, Tab 57, Page 1115
		17/06/2020	Volume 2, Tab 57, Page 1120
		17/06/2020	Volume 2, Tab 58, Page 1125
		17/06/2020	Volume 2, Tab 58, Page 1129
		17/06/2020	Volume 2, Tab 58, Page 1139
		18/06/2020	Volume 3, Tab 61, Page 1175
		18/06/2020	Volume 3, Tab 61, Page 1178
		29/06/2020	Volume 3, Tab 63, Page 1198
Coronavirus	11/03/2020-3/04/2020	11/03/2020	Volume 1, Tab 26, Page 299
		11/03/2020	Volume 1, Tab 26, Page 300
		13/03/2020	Volume 1, Tab 27, Page 305
		17/03/2020	Volume 1, Tab 30, Page 319
		17/03/2020	Volume 1, Tab 30, Page 320
		23/03/2020	Volume 1, Tab 32, Page 328
		23/03/2020	Volume 1, Tab 32, Page 329
		27/03/2020	Volume 1, Tab 33, Page 331
		27/03/2020	Volume 1, Tab 33, Page 332
		31/03/2020	Volume 1, Tab 34, Page 344
		31/03/2020	Volume 1, Tab 34, Page 388
		2/04/2020	Volume 1, Tab 35, Page 396
		2/04/2020	Volume 1, Tab 35, Page 588
		3/04/2020	Volume 2, Tab 36, Page 592
		3/04/2020	Volume 2, Tab 36, Page 593
Crohn's Disease	31/03/2020-2/04/2020; 20/05/2020, 17/08/2020	31/03/2020	Volume 1, Tab 34, Page 344
		2/04/2020	Volume 1, Tab 35, Page 477
		2/04/2020	Volume 1, Tab 35, Page 396
		20/05/2020	Volume 2, Tab 46, Page 702
		17/08/2020	Volume 3, Tab 72, Page 1439
Crush Injury	31/03/2020-2/04/2020; 14/05/2020-21/05/2020; 17/06/2020	31/03/2020	Volume 1, Tab 34, Page 344
		31/03/2020	Volume 1, Tab 34, Page 356
		2/04/2020	Volume 1, Tab 35, Page 396
		2/04/2020	Volume 1, Tab 35, Page 428
		2/04/2020	Volume 1, Tab 35, Page 429
		2/04/2020	Volume 1, Tab 35, Page 435
		14/05/2020	Volume 2, Tab 43, Page 681
		20/05/2020	Volume 2, Tab 47, Page 765
		21/05/2020	Volume 3, Tab 69, Page 1356
		21/05/2020	Volume 3, Tab 69, Page 1364
		17/06/2020	Volume 2, Tab 57, Page 1115
		17/06/2020	Volume 2, Tab 58, Page 1132
		17/06/2020	Volume 2, Tab 58, Page 1137
		17/06/2020	Volume 2, Tab 58, Page 1139
Cytokine Storm Syndrome	11/03/2020-2/04/2020; 17/06/2020-24/07/2020	11/03/2020	Volume 1, Tab 26, Page 300
		11/03/2020	Volume 1, Tab 26, Page 301
		27/03/2020	Volume 1, Tab 33, Page 332
		27/03/2020	Volume 1, Tab 33, Page 333
		31/03/2020	Volume 1, Tab 34, Page 344
		31/03/2020	Volume 1, Tab 34, Page 368
		31/03/2020	Volume 1, Tab 34, Page 388
		31/03/2020	Volume 1, Tab 35, Page 396
		2/04/2020	Volume 1, Tab 35, Page 414
		2/04/2020	Volume 1, Tab 35, Page 588
		17/06/2020	Volume 2, Tab 54, Page 851
		17/06/2020	Volume 2, Tab 58, Page 1150
		18/06/2020	Volume 3, Tab 60, Page 1182
		18/06/2020	Volume 3, Tab 65, Page 1253
		24/07/2020	Volume 3, Tab 66, Page 1298
Dementia |	31/03/2020-2/04/2020;	31/03/2020	Volume 1, Tab 34, Page 344
Cognitive Decline	21/05/2020-17/08/2020	31/03/2020	Volume 1, Tab 35, Page 396
		2/04/2020	Volume 1, Tab 35, Page 456
		21/05/2020	Volume 3, Tab 69, Page 1359
		4/06/2020	Volume 3, Tab 70, Page 1389
		4/06/2020	Volume 3, Tab 70, Page 1392
		17/06/2020	Volume 2, Tab 54, Page 849
		17/06/2020	Volume 2, Tab 54, Page 865
		17/06/2020	Volume 2, Tab 54, Page 876
		17/06/2020	Volume 2, Tab 54, Page 883
		17/06/2020	Volume 2, Tab 58, Page 1125
		18/06/2020	Volume 3, Tab 60, Page 1170
		7/07/2020	Volume 3, Tab 65, Page 1251
		24/07/2020	Volume 3, Tab 66, Page 1283
		17/08/2020	Volume 3, Tab 72, Page 1424
		17/08/2020	Volume 3, Tab 72, Page 1425
Disc Prolapse	13/03/2020-2/04/2020; 4/06/2020-24/07/2020, 17/08/2020	13/03/2020	Volume 1, Tab 27, Page 308
		31/03/2020	Volume 1, Tab 34, Page 339
		31/03/2020	Volume 1, Tab 34, Page 344
		31/03/2020	Volume 1, Tab 34, Page 364
		2/04/2020	Volume 1, Tab 35, Page 399
		2/04/2020	Volume 1, Tab 35, Page 438
		17/06/2020	Volume 2, Tab 54, Page 865
		4/06/2020	Volume 3, Tab 70, Page 1392
		18/06/2020	Volume 3, Tab 65, Page 1251
		24/07/2020	Volume 3, Tab 66, Page 1282
		4/06/2020	Volume 3, Tab 70, Page 1388
		17/08/2020	Volume 3, Tab 72, Page 1424
Failed Back Surgery	13/03/2020-2/04/2020; 17/06/2020-17/08/2020	13/03/2020	Volume 1, Tab 27, Page 308
		31/03/2020	Volume 1, Tab 34, Page 339
		31/03/2020	Volume 1, Tab 34, Page 344
		31/03/2020	Volume 1, Tab 34, Page 364
		31/03/2020	Volume 1, Tab 34, Page 373
		2/04/2020	Volume 1, Tab 35, Page 399
		2/04/2020	Volume 1, Tab 35, Page 438
		17/06/2020	Volume 2, Tab 54, Page 865
		17/06/2020	Volume 2, Tab 58, Page 1127
Condition	Date of Representations	Date of Screenshot	Exhibit IJW-1 Reference
18/06/2020	Volume 3, Tab 65, Page 1251
24/07/2020	Volume 3, Tab 66, Page 1282
4/06/2020	Volume 3, Tab 70, Page 1388
4/06/2020	Volume 3, Tab 70, Page 1390
17/08/2020	Volume 3, Tab 72, Page 1424
Fibromyalgia	31/03/2020-2/04/2020; 21/05/2020-18/06/2020	31/03/2020	Volume 1, Tab 34, Page 344
		31/03/2020	Volume 1, Tab 35, Page 396
		2/04/2020	Volume 1, Tab 35, Page 425
		2/04/2020	Volume 1, Tab 35, Page 470
		21/05/2020	Volume 3, Tab 69, Page 1359
		17/06/2020	Volume 2, Tab 54, Page 876
		17/06/2020	Volume 2, Tab 54, Page 886
		17/06/2020	Volume 2, Tab 58, Page 1125
		17/06/2020	Volume 2, Tab 58, Page 1127
		18/06/2020	Volume 3, Tab 61, Page 1178
Fracture Repair	31/03/2020-2/04/2020	31/03/2020	Volume 1, Tab 34, Page 344
		31/03/2020	Volume 1, Tab 34, Page 345
		2/04/2020	Volume 1, Tab 35, Page 398
		2/04/2020	Volume 1, Tab 35, Page 446
Gadolinium Poisoning	31/03/2020	31/03/2020	Volume 1, Tab 34, Page 344
Hearing Loss	31/03/2020-2/04/2020	31/03/2020	Volume 1, Tab 34, Page 344
		2/04/2020	Volume 1, Tab 35, Page 473
Hospital Infections (MRSA, VRE)	31/03/2020; 14/05/2020- 17/06/2020	31/03/2020	Volume 1, Tab 34, Page 344
		14/05/2020	Volume 2, Tab 41, Page 616
		20/05/2020	Volume 2, Tab 45, Page 693
		4/06/2020	Volume 3, Tab 70, Page 1369
		17/06/2020	Volume 2, Tab 54, Page 840
Irritable Bowel Syndrome	31/03/2020-2/04/2020	31/03/2020	Volume 1, Tab 34, Page 344
		2/04/2020	Volume 1, Tab 35, Page 396
		2/04/2020	Volume 1, Tab 35, Page 432
Infertility	31/03/2020-2/04/2020	31/03/2020	Volume 1, Tab 34, Page 344
		2/04/2020	Volume 1, Tab 35, Page 396
Kidney Disease	31/03/2020-2/04/2020	31/03/2020	Volume 1, Tab 34, Page 344
		2/04/2020	Volume 1, Tab 35, Page 396
Liver Disease	31/03/2020-2/04/2020	31/03/2020	Volume 1, Tab 34, Page 344
		2/04/2020	Volume 1, Tab 35, Page 396
Lyme Disease	31/03/2020-2/04/2020; 21/05/2020-29/05/2020; 17/06/2020	31/03/2020	Volume 1, Tab 34, Page 344
		2/04/2020	Volume 1, Tab 35, Page 396
		2/04/2020	Volume 1, Tab 35, Page 414
		2/04/2020	Volume 1, Tab 35, Page 480
		21/05/2020	Volume 3, Tab 69, Page 1356
		21/05/2020	Volume 3, Tab 69, Page 1359
		29/05/2020	Volume 2, Tab 52, Page 804
		17/06/2020	Volume 2, Tab 54, Page 875
		17/06/2020	Volume 2, Tab 54, Page 876
		17/06/2020	Volume 2, Tab 57, Page 1115
		17/06/2020	Volume 2, Tab 58, Page 1129
		17/06/2020	Volume 2, Tab 58, Page 1139
Macular Degeneration	31/03/2020-2/04/2020	31/03/2020	Volume 1, Tab 34, Page 344
		2/04/2020	Volume 1, Tab 35, Page 396
		2/04/2020	Volume 1, Tab 35, Page 484
Multiple Sclerosis	31/03/2020-2/04/2020; 14/05/2020-17/08/2020	31/03/2020	Volume 1, Tab 34, Page 344
		31/03/2020	Volume 1, Tab 34, Page 359
		2/04/2020	Volume 1, Tab 35, Page 396
		2/04/2020	Volume 1, Tab 35, Page 491
		14/05/2020	Volume 2, Tab 42, Page 639
		14/05/2020	Volume 2, Tab 42, Page 646
		20/05/2020	Volume 2, Tab 46, Page 717
		20/05/2020	Volume 2, Tab 46, Page 724
		21/05/2020	Volume 3, Tab 69, Page 1356
		21/05/2020	Volume 3, Tab 69, Page 1359
		21/05/2020	Volume 3, Tab 69, Page 1363
		29/05/2020	Volume 2, Tab 52, Page 805
		17/06/2020	Volume 2, Tab 54, Page 849
		17/06/2020	Volume 2, Tab 54, Page 875
		17/06/2020	Volume 2, Tab 54, Page 876
		17/06/2020	Volume 2, Tab 54, Page 877
		17/06/2020	Volume 2, Tab 57, Page 1115
		17/06/2020	Volume 2, Tab 57, Page 1122
		17/06/2020	Volume 2, Tab 58, Page 1139
		18/06/2020	Volume 3, Tab 66, Page 1290
		24/07/2020	Volume 3, Tab 66, Page 1300
		17/08/2020	Volume 3, Tab 72, Page 1439
Muscular Dystrophy	31/03/2020-2/04/2020	31/03/2020	Volume 1, Tab 34, Page 344
		2/04/2020	Volume 1, Tab 35, Page 396
Motor Neuron Disease	31/03/2020-2/04/2020	31/03/2020	Volume 1, Tab 34, Page 344
		31/03/2020	Volume 1, Tab 35, Page 396
		2/04/2020	Volume 1, Tab 35, Page 497
		2/04/2020	Volume 1, Tab 35, Page 502
Osteoporosis	31/03/2020-2/04/2020; 24/07/2020; 17/08/2020.	31/03/2020	Volume 1, Tab 34, Page 344
		2/04/2020	Volume 1, Tab 35, Page 408
		2/04/2020	Volume 1, Tab 35, Page 507
		24/07/2020	Volume 3, Tab 66, Page 1300
		17/08/2020	Volume 3, Tab 72, Page 1439
Pancreatitis	31/03/2020-2/04/2020	31/03/2020	Volume 1, Tab 34, Page 344
		2/04/2020	Volume 1, Tab 35, Page 516
Paraplegia, Quadriplegia	31/03/2020; 14/05/2020- 17/06/2020	31/03/2020	Volume 1, Tab 34, Page 344
		14/05/2020	Volume 2, Tab 42, Page 644
		21/05/2020	Volume 3, Tab 69, Page 1359
		4/06/2020	Volume 3, Tab 70, Page 1390
		17/06/2020	Volume 2, Tab 54, Page 863
		17/06/2020	Volume 2, Tab 54, Page 866
		17/06/2020	Volume 2, Tab 54, Page 876
		17/06/2020	Volume 2, Tab 58, Page 1127
Psoriasis	31/03/2020-2/04/2020; 14/05/2020-17/08/2020	31/03/2020	Volume 1, Tab 34, Page 344
		31/03/2020	Volume 1, Tab 34, Page 346
		2/04/2020	Volume 1, Tab 35, Page 398
		2/04/2020	Volume 1, Tab 35, Page 529
		14/05/2020	Volume 2, Tab 42, Page 620
		20/05/2020	Volume 2, Tab 45, Page 698
		21/05/2020	Volume 3, Tab 69, Page 1356
		21/05/2020	Volume 3, Tab 69, Page 1363
		17/06/2020	Volume 2, Tab 54, Page 875
		17/06/2020	Volume 2, Tab 54, Page 877
		17/06/2020	Volume 2, Tab 57, Page 1115
		17/06/2020	Volume 2, Tab 57, Page 1122
		17/06/2020	Volume 2, Tab 58, Page 1139
		24/07/2020	Volume 3, Tab 66, Page 1300
		17/08/2020	Volume 3, Tab 72, Page 1439
Radiation Necrosis	31/03/2020-2/04/2020	31/03/2020	Volume 1, Tab 34, Page 344
		2/04/2020	Volume 1, Tab 35, Page 534
Reflex Sympathetic Dystrophy	31/03/2020	31/03/2020	Volume 1, Tab 34, Page 344
Spinal Cord Injury	31/03/2020-2/04/2020; 27/04/2020-17/06/2020	31/03/2020	Volume 1, Tab 34, Page 345
		31/03/2020	Volume 1, Tab 34, Page 356
		2/04/2020	Volume 1, Tab 35, Page 411
		31/03/2020	Volume 1, Tab 35, Page 464
		2/04/2020	Volume 1, Tab 35, Page 517
		2/04/2020	Volume 1, Tab 35, Page 526
		2/04/2020	Volume 1, Tab 35, Page 559
		27/04/2020	Volume 2, Tab 39, Page 608
		14/05/2020	Volume 2, Tab 41, Page 614
		14/05/2020	Volume 2, Tab 41, Page 616
		14/05/2020	Volume 2, Tab 42, Page 623
		14/05/2020	Volume 2, Tab 43, Page 679
		20/05/2020	Volume 2, Tab 45, Page 693
		20/05/2020	Volume 2, Tab 45, Page 701
		20/05/2020	Volume 2, Tab 47, Page 762
		27/05/2020	Volume 2, Tab 50, Page 782
		28/05/2020	Volume 2, Tab 50, Page 784
		28/05/2020	Volume 2, Tab 50, Page 789
		4/06/2020	Volume 3, Tab 70, Page 1379
		4/06/2020	Volume 3, Tab 70, Page 1381
		17/06/2020	Volume 2, Tab 54, Page 875
		17/06/2020	Volume 2, Tab 54, Page 876
		17/06/2020	Volume 2, Tab 54, Page 877
		17/06/2020	Volume 2, Tab 58, Page 1136
		17/06/2020	Volume 2, Tab 54, Page 863
		17/06/2020	Volume 2, Tab 54, Page 866
		17/06/2020	Volume 2, Tab 58, Page 1127
		17/06/2020	Volume 2, Tab 54, Page 859
		17/06/2020	Volume 2, Tab 56, Page 990
		21/05/2020	Volume 3, Tab 68, Page 1319
		4/06/2020	Volume 3, Tab 70, Page 1377
		4/06/2020	Volume 3, Tab 70, Page 1390
		17/08/2020	Volume 3, Tab 72, Page 1430
Spinal Instability	31/03/2020	31/03/2020	Volume 1, Tab 34, Page 344
Sensorineural Hearing Loss	31/03/2020-2/04/2020	31/03/2020	Volume 1, Tab 34, Page 344
		2/04/2020	Volume 1, Tab 35, Page 545
Stroke	13/03/2020-3/04/2020; 14/05/2020-18/06/2020	13/03/2020	Volume 1, Tab 27, Page 307
		13/03/2020	Volume 1, Tab 29, Page 316
		31/03/2020	Volume 1, Tab 34, Page 344
		31/03/2020	Volume 1, Tab 34, Page 349
		31/03/2020	Volume 1, Tab 35, Page 396
		2/04/2020	Volume 1, Tab 35, Page 411
		2/04/2020	Volume 1, Tab 35, Page 449
		2/04/2020	Volume 1, Tab 35, Page 461
		2/04/2020	Volume 1, Tab 35, Page 462
		2/04/2020	Volume 1, Tab 35, Page 465
		2/04/2020	Volume 1, Tab 35, Page 550
		3/04/2020	Volume 2, Tab 36, Page 596
		14/05/2020	Volume 2, Tab 42, Page 618
		14/05/2020	Volume 2, Tab 42, Page 619
		14/05/2020	Volume 2, Tab 42, Page 620
		14/05/2020	Volume 2, Tab 42, Page 623
		14/05/2020	Volume 2, Tab 42, Page 630
		14/05/2020	Volume 2, Tab 42, Page 638
		14/05/2020	Volume 2, Tab 42, Page 640
		14/05/2020	Volume 2, Tab 42, Page 646
		14/05/2020	Volume 2, Tab 42, Page 648
		14/05/2020	Volume 2, Tab 42, Page 650
		20/05/2020	Volume 2, Tab 45, Page 693
		20/05/2020	Volume 2, Tab 46, Page 698
		20/05/2020	Volume 2, Tab 46, Page 696
		20/05/2020	Volume 2, Tab 46, Page 701
		20/05/2020	Volume 2, Tab 46, Page 708
		20/05/2020	Volume 2, Tab 46, Page 716
		20/05/2020	Volume 2, Tab 46, Page 724
		20/05/2020	Volume 2, Tab 46, Page 726
		20/05/2020	Volume 2, Tab 46, Page 728
		21/05/2020	Volume 3, Tab 69, Page 1359
		28/05/2020	Volume 2, Tab 50, Page 784
		28/05/2020	Volume 2, Tab 50, Page 789
		4/06/2020	Volume 3, Tab 70, Page 1381
		29/05/2020	Volume 2, Tab 52, Page 805
		17/06/2020	Volume 2, Tab 54, Page 849
		17/06/2020	Volume 2, Tab 54, Page 859
		17/06/2020	Volume 2, Tab 54, Page 867
		17/06/2020	Volume 2, Tab 54, Page 876
		17/06/2020	Volume 2, Tab 54, Page 883
		17/06/2020	Volume 2, Tab 54, Page 886
		17/06/2020	Volume 2, Tab 58, Page 1125
		17/06/2020	Volume 2, Tab 58, Page 1126
		17/06/2020	Volume 2, Tab 58, Page 1129
		17/06/2020	Volume 2, Tab 58, Page 1149
		18/06/2020	Volume 3, Tab 60, Page 1170
		18/06/2020	Volume 3, Tab 61, Page 1178
		18/06/2020	Volume 3, Tab 66, Page 1290
Tarlov Cyst	31/03/2020-2/04/2020	31/03/2020	Volume 1, Tab 34, Page 344
		2/04/2020	Volume 1, Tab 35, Page 396
		2/04/2020	Volume 1, Tab 35, Page 563
Traumatic Brain Injury	13/03/2020-3/04/2020; 14/05/2020-18/06/2020	31/03/2020	Volume 1, Tab 34, Page 354
		31/03/2020	Volume 1, Tab 34, Page 357
		31/03/2020	Volume 1, Tab 35, Page 396
		31/03/2020	Volume 1, Tab 35, Page 460
		2/04/2020	Volume 1, Tab 35, Page 556
		2/04/2020	Volume 1, Tab 35, Page 570
		2/04/2020	Volume 1, Tab 35, Page 588
		3/04/2020	Volume 2, Tab 36, Page 595
		14/05/2020	Volume 2, Tab 42, Page 623
		14/05/2020	Volume 2, Tab 42, Page 624
		14/05/2020	Volume 2, Tab 42, Page 630
		14/05/2020	Volume 2, Tab 42, Page 632
		14/05/2020	Volume 2, Tab 42, Page 635
		14/05/2020	Volume 2, Tab 42, Page 637
		14/05/2020	Volume 2, Tab 42, Page 638
		14/05/2020	Volume 2, Tab 42, Page 639
		20/05/2020	Volume 2, Tab 46, Page 708
		20/05/2020	Volume 2, Tab 46, Page 715
		21/05/2020	Volume 3, Tab 69, Page 1356
		28/05/2020	Volume 2, Tab 50, Page 784
		28/05/2020	Volume 2, Tab 50, Page 788
		29/05/2020	Volume 2, Tab 52, Page 824
		17/06/2020	Volume 2, Tab 54, Page 849
		17/06/2020	Volume 2, Tab 54, Page 884
		17/06/2020	Volume 2, Tab 54, Page 875
		17/06/2020	Volume 2, Tab 54, Page 876
		17/06/2020	Volume 2, Tab 54, Page 883
		17/06/2020	Volume 2, Tab 54, Page 849
		17/06/2020	Volume 2, Tab 58, Page 1125
		17/06/2020	Volume 2, Tab 58, Page 1148
		18/06/2020	Volume 3, Tab 60, Page 1170
Ulcerative Colitis	31/03/2020-2/04/2020; 20/05/2020-21/05/2020; 17/06/2020	31/03/2020	Volume 1, Tab 34, Page 344
		31/03/2020	Volume 1, Tab 34, Page 345
		2/04/2020	Volume 1, Tab 35, Page 396
		2/04/2020	Volume 1, Tab 35, Page 398
		2/04/2020	Volume 1, Tab 35, Page 432
		2/04/2020	Volume 1, Tab 35, Page 477
		20/05/2020	Volume 2, Tab 46, Page 702
		21/05/2020	Volume 3, Tab 69, Page 1356
		21/05/2020	Volume 3, Tab 69, Page 1359
		21/05/2020	Volume 3, Tab 69, Page 1362
		17/06/2020	Volume 2, Tab 54, Page 875
		17/06/2020	Volume 2, Tab 54, Page 876
		17/06/2020	Volume 2, Tab 54, Page 877
		17/06/2020	Volume 2, Tab 57, Page 1115
		17/06/2020	Volume 2, Tab 57, Page 1121
		17/06/2020	Volume 2, Tab 58, Page 1139

ANNEXURE B – SUPPLEMENTARY STATEMENT OF AGREED FACTS

SUPPLEMENTARY STATEMENT OF AGREED FACTS

FEDERAL COURT OF AUSTRALIA
DISTRICT REGISTRY: VICTORIA

DIVISION: GENERAL  NO VID 558 OF 2020

SECRETARY OF THE DEPARTMENT OF HEALTH

Applicant

OXYMED AUSTRALIA PTY LTD (ACN 606 641 954) and another named in the schedule

Respondents

INTRODUCTION

1.This Supplementary Statement of Agreed Facts (SSAF) is made for the purposes of s 191 of the Evidence Act 1995 (Cth) jointly by the Applicant and the Respondents.

2.Defined terms in this SSAF have the same meaning as the defined terms in the Statement of Agreed Facts and Admissions filed on 14 April 2021.

SIZE AND FINANCIAL POSITION OF THE FIRST RESPONDENT (OXYMED)

3.During the Relevant Period, Oxymed:

3.1.employed Mr Hooper as director; and

3.2.engaged two sub-contractors for the purposes of the role of technical assistance and accounts manager.

4.In the 2018-2019 financial year, Oxymed’s turnover was $685,023 and gross profit was $512,328. The net profit for the year was $6,345.

5.In the 2019-2020 financial year, Oxymed’s turnover was $674,367 and gross profit was $473,989. The net loss for the year was $85,905.

6.During the Relevant Period:

6.1.Oxymed’s turnover was $352,206 prior to discounts; and

6.2.Oxymed’s turnover from HBOT services was $323,204 prior to discounts.

OXYMED’S PRACTICE

7.During the Relevant Period, the price of HBOT provided by Oxymed was $129.59 per 60 minutes of treatment.

8.During the Relevant Period, Oxymed treated 80 clients.

9.During the Relevant Period, 25 of those 80 clients treated by Oxymed suffered from the following conditions listed in Schedules A and B of the SAFA:

9.1.Posttraumatic Stress Disorder: 1 client

9.2.Chronic Fatigue: 2 clients

9.3.Stroke: 1 client

9.4.Cancer: 15 clients

9.5.Multiple Sclerosis: 2 clients

9.6.Spinal Cord Injury: 2 clients

9.7.Radiation Necrosis: 1 client

9.8.Quadriplegia: 1 client.

SALARY AND EMOLUMENTS OF SECOND RESPONDENT (MR HOOPER)

10.During the Relevant Period:

10.1.Oxymed paid Mr Hooper $12,500 in salary and director’s fees; and

10.2.$50,000 was withdrawn from the director loan account, which was in Mr Hooper’s and Ms Catherine Hooper’s name, by Mr Hooper.

Date: 20 July 2021 Matthew Garey
AGS lawyer Lawyer for the Applicant Date: 20 July 2021 Lawyer for the First Respondent Date: 20 July 2021 Lawyer for the Second Respondent