Secretary, Department of Health v Evolution Supplements Australia Pty Ltd (No 2)

In the Federal Court of Australia, the Secretary of the Department of Health initiated proceedings against Evolution Supplements Australia Pty Ltd and its director, Mr Keskin, for breaches of the Therapeutic Goods Act 1989 (Cth). The respondents had advertised therapeutic goods that did not comply with the Act. Evolution was found to have contravened section 42DLB(1) of the Act, while Mr Keskin was found to have contravened sections 42DX and 54B(3). The court was tasked with determining the appropriate pecuniary penalties for these breaches under section 42Y of the Act.

The court examined the principles relevant to the imposition of penalties, considering the gravity of the matters alleged and the evidence presented. The Secretary had the onus to prove the case to the requisite civil standard. The court considered expert evidence on the health risks associated with the impugned products and the contraventions of the Act. The court evaluated the conduct of Evolution and Mr Keskin, finding that Evolution had advertised a total of 97 impugned goods, 70 of which referred to substances included in schedule 4 of the current Poisons Standard, without proper authorisation. Mr Keskin was found to have known about the contraventions and failed to take reasonable steps to prevent them.

The court determined that Evolution was liable to pay a penalty of $11,000,000, and Mr Keskin was liable to pay a penalty of $1,000,000. These penalties were based on the gravity of the breaches and the need to deter future non-compliance with the Act. The court also ordered that Evolution and Mr Keskin pay the applicant's costs of and incidental to these proceedings.