Potential Path for Medtronic Infuse LawsuitsJul 8, 2013
As use of Medtronic’s bone growth product Infuse continues, so do the reports of people who’ve been injured following the procedure in which it was used.
According to a report from the Minneapolis Star-Tribune, pursuing legal action against the embattled medical device maker has not been easy, however. Hundreds of people are now struggling to find a way to hold Medtronic accountable and are being blocked, in many ways, by federal laws that almost completely protect a medical device maker from being hit with legal action.
The U.S. Food and Drug Administration (FDA) has passed rules in the past that block many lawsuits filed against a medical device maker like Medtronic. The rule concerns lawsuits filed by recipients of the Infuse bone growth product. This “pre-emption” rule blocks lawsuits in which a company like Medtronic has been accused of wrongdoing when their medical device has already been approved by the FDA, according to the Star-Tribune report. A number of lawsuits have already been dismissed because of this rule and it’s leaving many Infuse recipients frustrated.
That could change now, however. The Star-Tribune notes that Infuse recipients who’ve been injured after their surgeries are now seeking to push the angle that Medtronic illegally marketed Infuse for purposes not approved by the FDA.
Our previous reports note that a medical device maker is not allowed to promote a medical device for a use that it has not been approved to treat. It is not illegal for a doctor to use a medical device in this manner but if he got the idea to do so from the manufacturer, then there could be an avenue for legal help.
Infuse is a bone growth product that’s designed to replace the traditional bone graft — typically from the hip — in spinal fusion surgery. Infuse has been approved for use in the lower back; not for use in the upper back or neck.
A lot of Infuse recipients have been injured after their surgery and, based on this recent report, have been stymied in their attempts to seek legal action against Medtronic.
Injuries linked to Infuse include severe swelling around the neck and spine. This can have numerous effects, including some life-threatening injuries. Excessive bone growth has been blamed for blocking airways, causing difficulty swallowing and breathing. One study, based on our reports, has found that nearly 75 percent of Infuse recipients suffer excessive bone growth, also known as ectopic bone growth. Other injuries linked to Infuse include nerve injuries, chronic pain, and a condition known as retrograde ejaculation.
Medtronic had been under federal lawmakers’ microscope last year until a Department of Justice investigation into the safety of Infuse was suddenly stopped without notice and without any conclusion. The investigation centered on whether Medtronic was promoting Infuse for off-label purposes, according to The Star-Tribune.
If these initial lawsuits are successful in proving that Medtronic did promote Infuse for non-FDA approved off-label purposes, it could open the doorway to litigation for hundreds — perhaps more — of people who’ve been injured by the bone growth product.