Lawsuit Alleges Medtronic Infuse Caused Excessive Bone Growth on Spine

A Florida man has filed a lawsuit after experiencing excessive bone growth around his spine from side effects of Medtronic’s Infuse bone graft, alleging that the company illegally promoted the medical device off-label and then failed to warn about the serious risk of complications associated with using the product in ways that were never approved by the FDA as safe and effective. 

The complaint (PDF) was filed by Anthony Foster on July 27, in the U.S. District Court for the Northern District of Florida.

Medtronic Infuse is a bone morphogenetic protein (BMP), which is used to encourage bone growth and replace spinal disks by filling the gaps between vertebrae. It is promoted as an alternative to bone graft procedures where bone is harvested from another part of the body or from cadavers.

According to allegations raised in the Medtronic Infuse lawsuit, Foster received the bone growth protein during spinal surgery in November 2007, to address degenerative disk disease and persistent back pain.

Although the FDA only approved the Infuse for use during spinal surgery that involves a single-level anterior lumbar interbody fusion (ALIF), where the spine is approached from the front, the Medtronic Infuse has been widely used for other types of spinal surgery, which have been linked to an increased risk of severe and painful complications caused by excessive or ectopic bone growth.

Foster’s surgery involved a transforaminal lumbar interbody fusion (TLIF), where the spine is approached from the back. About 16 months later, Foster’s back pain began to return, but this time included weakness and loss of sensitivity, as well as retrograde ejaculation, which causes male semen to be directed into the urinary bladder instead of out of the urethra.

Following physical therapy to address the back pain, Foster’s problems continued to get worse until he required revision surgery in August 2011. At that time, Foster learned from different physicians that his problems were caused by bone growth complications of the Medtronic Infuse.

In 2008, the FDA issued an alert about the risks associated with off-label use of Medtronic Infuse, after receiving a number of reports involving serious complications and deaths, often involving use in the cervical spine where the bone growth problems may impact the airway.

Foster’s case joins a growing number of lawsuits filed over the Medtronic Infuse bone growth protein, which have been filed in state and federal courts throughout the country. The complaints charge Medtronic with negligence, designing and manufacturing a defective product, failure to warn, breach of warranty, and fraud. Many of the lawsuits also seek punitive damages against the company for its alleged reckless behavior in Infuse illegal promotions.