Medtronic Infuse Lawsuit
Infuse Side Effects
Infuse Bone Graft is a metallic, thimble-sized cage device filled with genetically engineered human protein implanted in the body to generate new bone growth. Infuse was created in the hope that it would help stabilize the spine after spinal fusion surgery. It has worked for thousands of people when used for the purpose for which it was approved; off-label use, however, has led to some serious "side effects."
The FDA approved Infuse Bone Graft in 2002 only for use in lower spinal surgery to promote bone growth. Medtronic, however, has promoted Infuse to doctors for non-FDA-approved surgeries, which include cervical or lumbar fusion. Such unapproved or off-label uses have caused serious, sometimes life-threatening problems that include:
- Uncontrolled bone growth
- Ectopic bone growth
- Inflammatory cyst formation
- Increased cancer risk (esp. pancreatic, breast and prostate)
- Difficulty swallowing, speaking, breathing
- Retrograde Ejaculation
- Respiratory failure
- Nerve damage
- Erectile Dysfunction
- Additional surgeries to remove unwanted bone formation
- Bone dissolution
- Worsened back and radiating leg pain
Contact an Infuse Lawyer today if you suffer after having received off-label use of Infuse.
Off-Label Uses and Marketing Issues
Off-label marketing occurs whenever a drug maker markets a drug for a purpose not approved by the FDA. Medtronic’s off-label promotions of Infuse and subsequent injuries reported as a result of those off-label uses have left the company vulnerable to litigation from victims of those off-label uses.
Medtronic also trained medical staffs to perform surgical procedures using Infuse in the neck (off label). The company also allegedly paid doctors millions to write articles promoting off-label use of Infuse and to publish that pro-Infuse propaganda in medical journals. All of this marketing for off-label uses behind the curtain was done without the FDA’s ever having approved Infuse for surgeries on the neck and cervical spine.
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