The Federal Court of Australia has ordered Oxymed Australia Pty Ltd (Oxymed) to pay $2 million for advertising medical devices intended to administer hyperbaric oxygen therapy in breach of the Therapeutic Goods Act 1989 (the Act). The devices were advertised for the treatment of serious diseases and medical conditions, including Alzheimer's disease, cerebral palsy, dementia, COVID-19, stroke, HIV/AIDS, cancer, depression and post-traumatic stress disorder.
The Court also ordered Mr Malcolm Hooper, the Director of Oxymed, to pay $1 million in penalties for aiding, abetting, counselling or procuring the contraventions of the Act by Oxymed.
In making those orders, the Court found that Oxymed's advertising was 'intended to engender in the unscientifically trained and vulnerable reader a perception of credibility as to the claims of [hyperbaric oxygen therapy] as a treatment' for the conditions in issue, and that the use of hyperbaric oxygen therapy to treat most of those conditions was not supported by scientific evidence. The Court further concluded that Oxymed and Mr Hooper 'have a practice of posting pseudo-scientific articles targeted at a vulnerable audience'.
The Court also concluded that, while hyperbaric oxygen therapy presented a limited risk of direct harm to patients, 'there is a potential for significant harm if patients with conditions such as cancer or HIV/AIDS defer or avoid orthodox evidence-based treatment' in favour of pursuing hyperbaric oxygen therapy. There was also a 'risk of substantial financial harm to patients' depending on the duration of the course of treatment.
"The Court's decision indicates the seriousness of the contraventions," TGA head Adjunct Professor John Skerritt said.
"It sends a very clear message to advertisers that they must comply with consumer advertising rules, or otherwise risk enforcement action and significant penalties. We will continue to take appropriate enforcement action against non-compliant advertisers to protect the most vulnerable people in Australia living with serious diseases and conditions".
In March 2020, the TGA fined Oxymed $63,000 for alleged illegal advertising of the hyperbaric oxygen therapy devices, by issuing a series of infringement notices. Oxymed did not pay the fine and court proceedings were initiated.
The medical devices advertised on the company's website and Facebook page were not included in the Australian Register of Therapeutic Goods (ARTG). Under the Act, therapeutic goods must be included in the ARTG before they can be lawfully advertised or supplied in Australia, unless a specific exemption applies.
Oxymed advertised on its website and Facebook page, hyperbaric oxygen therapy devices with references to serious forms of a disease, condition, ailment or defect, without being granted relevant authorisation to make the restricted and prohibited representations.
The Court has issued an injunction preventing Oxymed and Mr Hooper from advertising hyperbaric oxygen therapy devices for a period of seven years that have not been included in the ARTG, or in a way that refers to prohibited or restricted representations.
Oxymed and Mr Hooper have been ordered to pay the Department of Health's costs of the court proceedings.
Information and resources about Australia's advertising rulesfor therapeutic goods are published on the TGA website.
The TGA encourages the reporting of suspected non-compliant advertising.
If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices online to the TGA.
