The TGA has launched federal court action against a leading medical technology company over its alleged unlawful supply of an unapproved treatment.
In its federal court filing, the regulator has alleged that between 1 September 2015 and 31 January 2020, Medtronic supplied 16,290 units of the INFUSE Bone Graft Kit to 108 hospitals. The kit was not registered for use in Australia with the TGA alleging each instance of supply was unlawful. The regulator says the maximum penalties add up to $19.5 million.
The filing says the kit is comprised of two separately packaged parts: a metallic spinal fusion cage (Cage); and, a kit (Kit) that contained a recombinant human bone morphogenetic protein, a vial of sterile water for injection, an absorbable collagen sponge, empty syringes and corresponding needles.
The Kit is used to stimulate bone growth in patients with degenerative disc disease. However, the TGA says it has never approved the Kit for use without the Cage.
"The Kit contained a medicine which was a prescription medicine, and therefore considered to be a relatively high risk therapeutic good," says the court filing.
"Before it was supplied not as a component of the Device, Medtronic should have applied under s 23 of the Act for registration of the Kit (namely, the medicine and other therapeutic goods within it) on the ARTG [Australian Register of Therapeutic Goods]. The Secretary would have been required to evaluate whether its quality, safety and efficacy for the purposes for which it was to be used had been satisfactorily established: s 25(1) of the Act."
The regulator said, "The Kit was used in a range of surgeries outside of the intended purpose for which the medical device (i.e., the Kit and LT Cage) was approved by the TGA. Evidence provided to the TGA indicates the Kit was used in procedures on the clavicle, hand, scapula, knee, leg, foot, jaw and used in procedures on children (who were not yet skeletally mature).
"The Kit, or the medicine and other therapeutic goods within it, had not been assessed for efficacy or safety nor approved by the TGA for use in these circumstances."