Did Medtronic sell an unsafe product? (Star Tribune - Business)
Under fire, the company looks to a top researcher to answer questions about its big seller Infuse.
For Dr. Harlan Krumholz, numbers tell stories.
The pioneering Yale University cardiologist's medical sleuthing -- called "outcomes research" -- involves studying how sick people are treated, then analyzing the results for clues on how to better care for them, often in a more-efficient and cheaper way.
His methods have attracted wide attention. Forbes magazine called him "the most powerful doctor you never heard of."
The latest challenge for Krumholz involves applying his techniques to a signature product from Medtronic Inc., the world's largest medical-device company. The back surgery product, Infuse, has long been a top seller, reaping $700 million a year for the Fridley-based company.
But that success has been marred by allegations that Medtronic paid illegal kickbacks and sham royalties to doctors to entice them to use Infuse in ways regulators hadn't approved, possibly putting patients at risk. Some critics say researchers with financial ties to the company have understated serious compl...
