Past Covidien, ev3 Activities are Costing Medtronic a Hefty Sum

Sometimes acquiring other companies means taking the bad with the good. In Medtronic's case, that means settling multiple Department of Justice claims against ev3, a business Medtronic owns by way of its Covidien acquisition. Covidien bought ev3 in 2010 and Medtronic finalized its $49.9 billion Covidien deal in early 2015. Now, Medtronic is paying the price for activities that ev3 allegedly conducted between 2005 and 2009 involving the Onyx Liquid Embolic System. FDA approved the device in 2005 as a liquid embolization device that is surgically injected into blood vessels to block blood flow to arteriovenous malformations in the brain. Although the device was only approved for use inside the brain, the DOJ claims ev3 sales reps encouraged surgeons to use Onyx in large quantities for procedures outside the brain. FDA officials reportedly raised concern in 2008 about the use of Onyx outside the brain and told ev3 it would have to conduct a study to gain approval for outside-the-brain procedures. Investigators say that instead of conducting such a study, ev3 reps attended surgical procedures and provided explicit instructions to surgeons about how to use the device for unapproved procedures outside the brain, including in greater quantities than would be used in the brain. The company also allegedly set up a system of sales quotas and bonuses that incentivized reps to sell Onyx for unapproved uses and trained its sales force on how to instruct...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news