When Off-Label Use Becomes a Problem

When Off-Label Use Becomes a Problem

Australian food and drug regulators are investigating Medtronic and the selling of a controversial product, Infuse Bone Graft, without a safety component necessary for compliance. The Minnesota-based medical device giant denies the product was pulled due to compliance issues. In the meantime, a whistleblowing former employee told regulators the company has been selling the product without the safety feature—a titanium LT-cage device. While the company maintains doctors have the choice to use the product in an off label manner, the risks of doing so appear significant. A government investigation in Australia ensues. 

Wrongdoing in Australia?

Recently, Jim Spencer and Joe Carlson with the Minneapolis StarTribune report on an interview with Craig Moy, a consultant with a group representing private health insurance funds in Australia (Private Healthcare Australia or PHA), who commented, “There has never been an LT-Cage funded by one of our [private] health insurance funds in the 14-plus years Infuse was sold in Australia. Australian payers have paid up at least $350 million for Infuse since 2006 estimates PHA. Apparently little of these funds went to the...

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