Posted by on Feb 25, 2015 in Medical Malpractice | 0 comments

Arizona-based medical device manufacturer Medtronic is feeling the heat as an increasing number of individuals are filing claims of product liability for its INFUSE Bone Graft product. Approved in 2002 by the Food and Drug Association (FDA) for use in specific spinal repairs, in 2004 for tibia procedures, and in 2007 for dental applications, INFUSE Bone Graft was lauded as a breakthrough in bone surgery.

INFUSE Bone Graft is used to encourage bone growth with the use of recombinant human bone morphogenetic protein (rhBMP-2), a synthetic protein. It is used in areas where bone needs to be grown.

The product ran into trouble when complaints started coming in that Medtronic concealed potentially harmful side effects from using the product from the medical community and the public and that it marketed the product for off-label uses. Quite a few lawsuits have been filed against product manufacturers, such as Medtronic for INFUSE Bone Graft, in both federal and state courts for various injuries, including infections, bone and nerve damage, urinary complications, sterility, and some contend that there is a link between the product and cancer.

In one case, a 33-year-old construction worker decided to have bone graft surgery in 2011 when pain from back injuries sustained in a car accident persisted. He was assured that the surgery would improve his quality of life and reduce his pain. Instead, the hardware supporting the bone graft shifted to his nerve root and made his back pain worse to the point of debilitation. Revision surgery was only partially successful and now the man can only walk with a cane and is on disability as he is unable to work.

Medtronic has already paid a hefty sum in fines to the Department of Justice for off-label marketing of INFUSE and been involved in two whistleblower lawsuits as early as 2006, as well as a shareholder lawsuit that ended in a $85 million settlement. The latest legal troubles for Medtronic has not yet been referred to multidistrict litigation (MDL) but with more and more lawsuits being filed, there are speculations that an MDL is not far off.

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