Medtronic Infuse Lawsuit
April 1, 2012The largest medical technology company in the world, Medtronic, Inc. is currently the subject of multiple lawsuits in response to its Infuse bone graft product. Infuse is a bone graft product that contains rhBMP-2 (recombinant human bone morphogenetic protein). This protein occurs naturally, but is used in Infuse to initiate bone growth in specific areas of the spine. Infuse has been approved by the FDA for lumbar spine procedures, however at this time, Medtronic is being investigated by the Department of Justice as well as the Senate for promoting off-market uses for Infuse, including cervical spine (neck) procedures. The FDA also failed to approve Amplify, a stronger version of Infuse citing possible cancer risks.
Medtronic Infuse Conflicting Studies
In June of 2011, a group of spine experts joined together to publicly refute the findings of several research studies performed by people with financial ties to Medtronic. In the most recent fiscal year, Medtronic made nearly $900 million from Infuse alone, which is used in ¼ of all spinal fusions in the United States. The findings of this independent group of spine specialists was published in The Spine Journal. Basically, the researchers who have received any money from Medtronic deny the presence of any risks or complications associated with the Infuse product. These financial interests of the researchers created a conflict of interest, and the result was detrimental to the safety of patients. In all of these studies, the existing interest conflicts were either unclear of not reported at all. As a result, many recipients of Infuse treatment were not informed regarding any potential risks; as a result, some choose to file an Infuse Lawsuit against Medtronic, Inc.
Medtronic Infuse ComplicationsSeveral research studies related to Medtronic Infuse have been accused of significantly overstating its benefits, as well as denying that the product has been linked to any adverse effects or complications. Several other experts have suggested that the actual rate of complications after treatment with Infuse ranges from 10-50% of cases depending on how it was used. Some of the reported Medtronic Infuse complications include:
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