As Janet Moore reports for the Star Tribune of Minnesota, there's nothing wrong—well, it's not illegal, anyway—to use a medical device in surgical procedures that haven't been approved by the FDA.
Such use is known as "off-label."
It's not illegal to use, but it is illegal to promote such use, and that's exactly what Medtronic appears to have been doing throughout a period of years where its Infuse bone graft device raked in $700-900 million annually.
The Case of Laurie DeNeui
Nothing illustrates the off-label issue with Infuse more than Moore's report about 46-year-old (former) schoolteacher Laurie DeNeui.
DeNeui had surgery to treat neck pain after an apparent car accident, and her surgeon used the Infuse product. This was in 2005, before the FDA warned against using Infuse in neck procedures.
Nonetheless, Infuse had never been approved by the FDA for use in the neck. As a result of an aggressive off-label promotional campaign, roughly 85 percent of procedures involving Infuse were off-label.
One of those cases is Ms. DeNeui, and she is now permanently disabled.
The Case Against Medtronic
After a long and unlawful string of off label promotion, three U.S. Senators are demanding answers from like Medtronic.
Liz Jones Hollis reports for Fierce Medical Devices reports that the Senators want to know about the "financial relationships" between paid researchers who glossed over the side effects of Infuse-side effects that include incapacitating swelling in the throat that have caused permanent injury and even death in some patients-researchers paid by Medtronic.
They also want to know about Medtronic's "post-market surveillance," as Hollis reports, a term that refers to a medical device maker's methods of determining adverse outcomes after surgery.
But, with that billion-dollar market for treating backpain, and with Infuse used for off-label procedures in 85 percent of all cases (Laurie DeNeui's case just one of thousands) it seems likely that Medtronic is not entirely capable of conducting sufficient post-market surveillance.
The market for treating back pain is just too lucrative.