The Wall Street Journal published a report today that the federal probe into Medtonic's Infuse is over. The government led investigation began in 2008, and looked into whether the leading company in the spine industry had illegally marketed the synthetic protein for unapproved intra-operative use. The announcement ends the civil and criminal inquiry with no further findings, nor will there be any civil penalties. Unlike Stryker and its employees which had been raked over the coals, eventually leading to Stryker pleading guilty and agreeing to pay a $15 million dollar fine for misbranding its product, Medtronic has dodged a major bullet.
In Medtronic's case, this had severely cut into sales over the past few years, leaving the industry leader no other recourse than to independently employ Yale University's Dr. Harlan Krumholz to investigate the research backing the products safety and efficacy without having any surgeon consultant influence. Krumholz is looking to liberate the data and let the science speak for itself. If all goes according to plan, the data from two independent sites, one in Oregon and the other in the United Kingdom should be finalized by this summer.
Hopefully, this entire experience will temper Medtronic's arrogance and get them focused once again. Who knows maybe Omar is really what the company needed? The good old days are over, and regardless what some of our readers espouse regarding the big, bad, and evil FDA, if you never have sat in on one of these panel meetings when the consultants are spewing their company paid propaganda, maybe Medtronic would have never gotten itself into this position in the first place. But then, when Jesus takes the wheel in the operating room, it doesn't matter how well Medtronic may have wanted to police Infuse, when its it God's hands the indications begin to get stretched. TSB wants to know what our readers think? Will this help or hinder Big Blues image?
Jesus take the wheel, take it from my hands
Cause I can't do this on my own, I'm letting go
So give Medtronic one more chance to save them from
the road their on, Jesus take the wheel.