THE Federal Court of Australia has ordered Medtronic Australasia Pty Ltd to pay $22 million in penalties for unlawfully supplying 16,267 units of the Infuse Bone Graft Kit between Sep 2015 and Jan 2020 (PD breaking news).
The court also mandated Medtronic to pay $1 million towards the TGA's legal costs.
The penalty, the largest ever under the Therapeutic Goods Act 1989, follows proceedings initiated by the TGA in 2021.
Medtronic was found to have supplied the Infuse Bone Graft Kit without the required spinal cage, despite its listing in the ARTG only allowing it to be supplied with the cage.
TGA head Prof Anthony Lawler reinforced the importance of compliance to ensure Australians receive safe and effective medical products.
"This significant penalty serves as a reminder to sponsors and others in the therapeutic goods industry to take their obligations seriously," said Lawler.
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