InFUSE Bone Graft LawsuitGet the Compensation You Deserve
What is the InFUSE™ Bone Graft/LT-Cage?
The InFUSE™ bone graft is a genetically engineered protein that is designed to stimulate bone growth. In July 2002, the FDA approved InFUSE™ for one single type of surgery. The only way InFUSE™ should have been used, was in a lumbar surgery accessed through the front of the body and using the LT-Cage™ Lumbar Tapered Fusion Device.
However the vast majority of InFuse surgeries were performed in ways that were not approved by the FDA. Medical devices or drugs are only supposed to be used in approved ways, which are put on the product label by the FDA. Any other use is referred to as “Off-Label” use, and can be incredibly dangerous.
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What Can Off Label Uses of InFUSE Do To Patients?
Unapproved uses of the InFUSE bone graft can have dangerous and life threatening consequences to patients. If you or a loved one had a spinal fusion surgery and suffered from any of the following complications, contact The Balkin Law Group for a free case evaluation.
- Dangerous, uncontrolled bone growth
- Retrograde ejaculation or sterility in men
- Respiratory problems and complete respiratory failure
- Painful neck and shoulder tissue swelling
- Ectopic bone growth
- Airway Compression
- Difficulty breathing, swallowing, or speaking
- Swelling of the tissues of tongue, throat, mouth, and tissue
- Upper chest swelling
- Forming inflammatory cysts
- Nerve damage
- Permanent disabilities
- Total or partial paralysis
If you or a loved one have suffered from any of these conditions following an InFUSE™ Bone Graft spinal fusion, you could receive financial compensation.
Why Were So Many Off Label Surgeries Performed?
In a 2011 article in Spine Journal, a group of several doctors who specialize in spine surgeries and spine health publicly denounced the findings several medical professionals that had previously supported InFUSE. These medical professionals received substantial compensation from Medtronic for publishing a series of articles about the InFUSE bone grafts where they:
- Overstated the benefits of InFUSE™ bone graft
- Claimed there were little to no risks associated with it
- Promoted” Off-Label” surgeries using InFUSE™
Between 1996 to 2010, Medtronic paid over $210 million in consulting fees and royalties to these medical professionals to publish articles and publicly promote InFUSE. During this time, doctors performed thousands of “off label” surgeries using the InFUSE and the patients did not understand the true risks. Many suffered terrible surgical complications. The US Senate began investigating Medtronic in 2012, and unearthed that Medtronic actively promoted off-label surgeries and attempted to cover up potential risks.
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Filing an InFUSE Lawsuit against Medtronic
Many people have filed lawsuits against Medtronic after suffering surgical complications from the InFUSE bone graft for:
- Medtronic manufacturing a defective product and failing to warn patients of risks
- A negligently faulty product design and failure to recall the product when defects were detected
- fraudulently misrepresenting the benefits of the InFUSE
- Concealing side-effects and dangers
- Medical malpractice and medical negligence
- The breach of both express and implied warranties
If you or a loved one have suffered surgical complications after an InFUSE bone graft surgery, The Balkin Law Group can help you get the compensation you need. We are a national law firm, with experienced medical malpractice and product liability lawyers in every state. If you are looking for legal compensation, don’t fight Medtronic alone. “Hire the Bull!”