Did Medtronic Sell an Unsafe Product?

NOVEMBER 12, 2011 - Fridley, Minnesota is home to Medtronic, the largest medical device company, and an article in the Star Tribune, November 12, Saturday, asks Did Medtronic sell an unsafe product? (here) The product in question is used for back surgery. Infuse is a top seller, but critics say that kickbacks to doctors to use Infuse off-label, for example in neck surgery, have helped sales and may have put patients at risk. Those charges are under investigation by Congress and the U.S. Department of Justice.

Companies cannot market their device for off-label use, but doctors can use a device as they want. There are currently four whistleblower lawsuits that have been filed by former Medtronic employees that revealed the lavish trips for “training” and payouts to doctors as compensation for “consulting”.

Infuse was approved by the FDA in 2002 for use in spine fusion surgery to correct a deformity or eliminate pain using a recombinant bone morphogenetic protein-2.

The Star Tribune investigated the accounts of kickbacks and found that Medtronic paid $61 million in consulting fees, royalties and educational training during fiscal 2011, with the bulk being paid to spine specialists.

Collaboration with Physicians

Is a financial relationship with a physician wrong? Medtronic says no, in fact, the company says physicians should be fairly compensated when they invent a new product and such relationships are another way to ensure the medical device is safe.

The researcher who is the focus of this story, Dr. Harlan Krumholz, a Yale cardiologist, will receive another $2.5 million grant along with patient data so he can compile an analysis of Infuse. Dr. Krumholz testified on behalf of Vioxx victims after researching Merck and finding information that should have been made public but wasn’t.

A Spine Journal publication (Abstract here) suggested doctors on the receiving end from Medtronic, underreported complications from Infuse by 10 to 50 times.