Medtronic’s Infuse Bone Growth product was originally marketed as an innovative way to perform spinal fusion surgeries by using a genetically engineered protein to stimulate bone growth in the spine. However, nearly 85% of procedures using Infuse are now off-label – which is causing concern about who’s liable for its related injuries.
Who’s Responsible for Infuse Injuries?
According to a report by HealthWorks Collective, nearly 85% of procedures using Medtronic’s Infuse Bone Growth product are off-label – meaning they haven’t been approved by the U.S. Food & Drug Administration for those particular uses. The question becomes who is responsible for injuries sustained by the product in these cases?
While many medical devices and pharmaceuticals are used off-label, determining who is ultimately responsible for injuries can be unclear. If a doctor decides to use a product in a way that was not approved, he or she may be held responsible. However, in the case of Medtronic’s Infuse, there is mounting evidence that the company itself was telling doctors to use the product in unapproved ways.
The issue of responsibility has become a growing concern, as spinal fusions have increased by an astonishing 1500% (that’s 1-5-0-0) between 2002 and 2007 among patients on Medicare – and the agency is now crying foul.
Medicare executives point to the FDA’s warning that using Infuse off-label in the cervical spine could lead to deadly Infuse side effects and complications, such as:
- Difficulty swallowing (dysphagia), breathing or speaking
- Extraneous bone growth
- Neck and throat swelling, resulting in compression of the airway and neurological structures in the neck
- Nerve damage
Medtronic faces numerous lawsuits from patients who have been injured and may soon become entangled in a battle with the government over Medicare costs associated with Infuse injuries.
Have You Been Injured?
If you’ve been injured by Medtronic’s Infuse Bone Growth, contact The Driscoll Firm, LLC, and speak to one of our experienced and aggressive personal injury attorneys. Let us evaluate your situation and determine whether you might be entitled to compensation for medical bills, lost income, physical and emotional pain and suffering and more. We’ve recovered over $170 million for our clients, and many of those cases were against major medical device manufacturers. Let our experience help you get the compensation you deserve.