Medtronic Australasia Pty Ltd ordered to pay $22 million - the largest ever penalty for unlawful supply of therapeutic goods

The Federal Court of Australia has ordered - external site Medtronic Australasia Pty Ltd (Medtronic) to pay $22 million in penalties for unlawfully supplying 16,267 units of the Infuse Bone Graft Kit between 1 September 2015 and 31 January 2020.

The Court's judgment comes after the Therapeutic Goods Administration (TGA) commenced proceedings against Medtronic in August 2021. The Court has also ordered that Medtronic pay $1 million as a contribution to the TGA’s legal costs.

This penalty is the largest ever imposed for contraventions of the Therapeutic Goods Act 1989 (Cth).

Australian law generally requires that therapeutic goods are entered in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied in Australia. While the Infuse Bone Graft Kit was entered in the ARTG for supply with a separately packaged spinal cage (the LT Cage), that entry in the ARTG did not allow the Kit to be supplied without the LT Cage. Medtronic unlawfully supplied the Kit without the LT Cage.

Professor Anthony Lawler, Deputy Secretary of the Department of Health and Aged Care and head of the TGA, said that “this significant penalty serves as a reminder to sponsors and others in the therapeutic goods industry to take their obligations seriously.

“Medicines and medical devices supplied to Australians must be assessed by the TGA for safety, efficacy, and performance in the exact way they will be supplied to patients. This protects Australians by ensuring they have access to the safest products available.

“The TGA’s highest priority is to protect the health and safety of the Australian public”. 

If you are a consumer and have questions about the Infuse Bone Graft Kit, you should speak to your treating doctor in the first instance. If you, or your treating doctor, wish to report a problem or side effect of the Infuse Bone Graft Kit please visit the TGA website: Report a problem or side effect.

If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices online to the TGA.

Contact for members of the media:

• Email: news@health.gov.au
• Phone: 02 6289 7400