Even though the FDA issued a warning that there were risks associated with the use of the bone graft on the cervical spine (i.e., neck) and that the InFuse had caused "life-threatening complications" back in July 2008, Medtronic sales representatives still allegedly encouraged physicians to use the InFuse Bone Graft off-label. Even though the FDA has approved this medical device only to treat degenerative disc disease (a spinal condition) and open fractures of the tibia—any other treatment is considered "off-label" and not FDA-approved—it was still marketed for neck surgery.
In December 2008, The Wall Street Journal reported that a California woman went into respiratory arrest and died after neck surgery. She was "kept alive by artificial means" and passed away August 30. The family of the woman filed a wrongful death lawsuit, claiming that her death was due to the InFuse Bone Graft.
Her surgery took place on August 21, 2008, about seven weeks after the FDA had warned that InFuse in-neck surgery had caused "life-threatening complications," and about two weeks after the WSJ (09/08/08) reported that FDA records showed approximately 200 patients who had experienced serious complications after the bone graft was used—the majority of the complaints were due to off-label use.
Other serious complications associated with the Medtronic Infuse Bone Graft include inflamed tissue (caused by the artificial protein contained in the device) and possibly bone growth in areas outside the surgical site if the device isn't properly placed or Infuse Graft materials leak.
Although promoting a drug or medical device "off-label" is illegal, it is legal for health care professionals to prescribe an FDA-approved drug or medical device for a non-indicated (off label) use, such as using antidepressant Chantix as a smoking cessation medication, or in this case, the InFuse bone graft in neck surgery. A number of lawsuits allege that Medtronic representatives actively promoted the Infuse Bone Graft for off-label use, even with the knowledge of serious risks involved.
READ MORE MEDTRONIC INFUSE BONE GRAFT LEGAL NEWS
According to Infuse Bone Graft attorneys, Medtronic has not complied with the FDA's "Recommendations for Good Reprint Practices," and more…