Medtronic Infuse (BMP-2) Bone Graft & Infuse Lawsuits
If you or a loved one has suffered from Medtronic Infuse Bone Graft problems after undergoing a cervical spine surgery with the product, you may have legal recourse to recover financial compensation for damages. Medtronic and its doctors deemphasized complications, and failed to properly disclose serious and potentially life-threatening side effects of the Infuse Bone Graft treatment. Those affected now have the opportunity to take legal action for their Medtronic Infuse problems. Medical bills and lost wages are among the damages which may be available to injured patients who seek recovery through Medtronic Infuse bone graft lawsuits.
Some of the items that Sanders Phillips Grossman can recover for you regarding your possible Medtronic Infuse Bone Graft claim are:
- Any hospitalization costs incurred regarding your Medtronic Infuse Bone Graft procedure.
- Past and future medical bills that you incurred or will incur due to the Infuse procedure.
- Costs regarding any revision surgery to diminish or attempt to clear us side effects cause by the Medtronic Infuse Bone Graft procedure.
- Pain and suffering caused by the side effects of complications of the Medtronic Infuse Bone Graft surgery.
- Lost wages due to the complication caused by the Infuse Bone Graft side effects.
- Disability payments for being debilitated from the Medtronic Infuse Bone Graft procedure.
- Reduced earning capacity from injuries caused by the Infuse Bone Graft complications.
What you should know about your Medtronic Infuse Bone Graft claim
Infuse is the trade name for bone morphogenetic protein or BMP-2, which promotes bone growth. The BMP-2 is placed inside a small cage and then implanted in the patient.
Manufactured by Medtronic, the nation’s largest maker of medical devices, over 100,000 U.S. patients in the U.S. annually undergoing spinal fusion surgery receive Infuse. Many of these patients received Infuse in either the lumbar or cervical spine, areas of the spine where Infuse has not been approved for surgery.
Infuse Approved for Limited Back Surgery
The U.S. Food and Drug Administration approved Infuse in 2002 for one specific type of spine surgery – anterior approach lumbar fusion.
The FDA did not approve the use of Infuse in either lateral or posterior approach lumbar fusion surgeries. Nor has the FDA approved Infuse for use in the cervical spine (the portion of the spine that runs from the shoulders to the head).
Our Experienced Lawyers are ready for your Medtronic Infuse Bone Graft Claim
The Infuse Bone Graft can have serious complication when used in patients. Sanders Phillips Grossman is currently gathering clients and data for a large mass tort claim. A mass tort is a single tort (Case or Claim) that results in injury to many victims, and therefore involves numerous plaintiffs suing one defendant (or several defendants) who acted negligently. In most mass tort cases, the various individual plaintiffs must be suing based on harms cased by a single common product. In a mass tort case, claims are decided separately but presented by the attorney together. Each client will receive a possible settlement based on their recorded damages.
This lawsuit is being brought against Medtronic for the following reasons:
- Medtronic’s failure to accurately report the side effects from its clinical trials
- Medtronic’s failure to report that many of the authors who studied and promoted its product had significant financial ties to the company
- Infuse Bone Graft can cause severe problems with nerves and spinal cords
- Off-label use of Infuse Bone Graft can lead to severe side effects
Medtronic Researchers Downplay Severity of
Infuse Bone Graft Complications
According to a Medtronic Infuse Study Published in The Spine Journal in July 2011, Medtronic-Paid Researchers Downplayed Serious Infuse Side Effects, Including Cancer, Ectopic Bone Growth, Retrograde Ejaculation, Male Sterility, Infections, Bone Dissolution and Worsened Back and Leg pain.
Adverse events have been filed in over 290 cases with the FDA. Many are raising questions about the safety of the Infuse Bone Graft and the credibility of the dozens of papers promoting the widespread and even off-label use of the product. Several patients have already filed lawsuits against Medtronic, claiming the billion-dollar medical technology company promoted the product for off-label use and purposefully downplayed its dangers.
Infuse Side Effects and Infuse Bone Graft Injuries
When any medical device, including Infuse, is used by a physician in an off-label use, the patient must be informed of this off-label or experimental use, and the risks of such use must be fully disclosed to the patient prior to the surgery, so that the patient may make an informed decision as to whether or not he or she wishes to consent to the off-label use.
Many patients who have received off-label use of Infuse in their spine were not informed of the off-label nature of the surgery, and were not told of the risk of serious complications linked to Infuse.
The reported side effects from the off-label use of Infuse include:
- Ongoing or chronic radiating pain in the legs or arms (i.e., radiculopathy or radiculitis)
- Sterility, retrograde ejaculation, or other urogenital injuries in male patients
- Ectopic bone growth or uncontrolled bone growth in the spinal canal
- Nerve injuries causing chronic pain
- Cervical spine surgeries: acute severe neck swelling several days after surgery resulting in death or permanent injury
Serious Infuse Side Effects Allegedly Not Disclosed
The Spine Journal, an international medical journal, last year criticized research by other experts that supported the widespread use of Infuse as “biased and corrupted research.”
The Journal reported that in none of 13 studies funded by Medtronic were any Infuse adverse events disclosed. Data provided to U.S. regulators and other publications, however, showed that up to 50 percent of the patients who received Infuse may have suffered side effects, including infection, pain, cyst formation, and infertility in men, the reviewers said.
When Medtronic first initiated studies in 1999 on the bone morphogenetic protein, researchers discovered 70 percent of patients developed unnatural bone growth. This serious condition called ectopic bone growth, was never given emphasis to its patients. The ectopic bone growth can cause complications such as:
Contact Sanders Phillips Grossman for a Free Medtronic Infuse Bone Graft Case Evaluation!
At Sanders Phillips Grossman we are now seeking those injured by the use of Medtronic Infuse Bone Graft. We are looking for compensation for those that are injured. If you or a loved one has been injured or lost their life due to complications of the Medtronic Infuse Bone Graft procedure, we are here to help. Call us immediately of fill out the no obligation Free Case Review and one of our legal administrators will contact you. Sanders Phillips Grossman has a “No Fee Promise”. If we do not recover any compensation for your Medtronic Infuse Bone Graft claim, then you owe nothing.