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Infuse Bone Graft Lawsuit

surgeons performing surgeryPatients across the country who received the Medtronic Infuse bone graft have experienced severe and debilitating complications related to the device.

If you have suffered injury or health complications as a result of implantation with the Infuse bone graft and have questions about your legal options, the product liability lawyers at Eisbrouch Marsh offer free consultations to discuss whether you may have a claim against the manufacturer.

Some of the warning signs of Infuse bone graft complications include:

  • Severe back or leg pain
  • Difficulty breathing or swallowing
  • Nerve pain that radiates through the body
  • Infection
  • Cancer

If you have suffered these or other symptoms, consider speaking with an Infuse bone graft attorney about your rights to compensation. With Eisbrouch Marsh on your side, you will receive an honest and expert assessment of your potential lawsuit against Medtronic.

About the Medtronic Infuse bone graft

The Infuse bone graft is a medical device used to repair degenerative spinal disc damage. It is made up of several parts – the LT Cage (a small, tapered, metallic cage) and a protein. The protein is an engineered human bone morphogenetic protein that mimics a protein naturally made by the human body.

The bone graft is designed to work by stimulating bone growth where it is implanted. A sponge made from a cow collagen, and containing the human bone morphogenetic protein, is inserted into the LT Cage. The LT Cage is then implanted between the vertebrae. The sponge releases protein to gradually encourage bone growth.

Unfortunately, the device may stimulate bone growth too well – some recipients have suffered from excessive bone growth, leading to pain and inflammation. Other complications tied to the Infuse bone graft include male sterility, cancer, infection, and bone degeneration.

FDA issued warnings about Infuse bone graft

The FDA approved the Medtronic Infuse bone graft in July 2002. The device was approved for use in the lower back. In 2008, the FDA issued a public notice that using morphogenetic protein, the material that promotes bone growth in the Infuse product, in the cervical (upper) spine can lead to life-threatening complications. Patients who received this type of bone graft in the cervical spine experienced swelling of the neck and throat, which led to airway compression and neurological damage in the neck. This cervical spine graft is an off-label use of the Medtronic Infuse device, which was never FDA-approved.

The federal government has concluded that Medtronic manipulated the public to sell more units of the bone graft device; the Senate Finance Committee issued a report in October 2012 stating that Medtronic improperly paid researchers to publish studies that inaccurately portrayed Infuse bone graft benefits. The committee spent 16 months investigating Medtronic, concluding that over a 15-year period, it paid physicians who authored studies $210 million.

Infuse bone graft lawsuit allegations

Plaintiffs have alleged that Medtronic failed to warn the public or physicians about the dangers of off-label use. Even more seriously, they allege that Medtronic stimulated its sales of the device by encouraging physicians to make off-label use of the bone graft stimulator. Off-label uses include using the device in unapproved locations such as in the cervical spine or implanting the engineered protein with the use of the LT Cage.

In order to prevail in a Medtronic Infuse bone graft lawsuit, a plaintiff needs to prove one of several things:

  • The product’s design makes it inherently unsafe;
  • The product was manufactured with errors; or
  • The manufacturer or distributor mislabeled the product or failed to provide proper safety warnings.

There are highly technical issues that must be made clear to a judge and jury. That is one reason going it alone is not the best route for a plaintiff. An experienced lawyer will help garner critical evidence and secure expert testimony so that justice can prevail.

What can an Infuse bone graft lawyer do for you?

A skilled attorney is necessary to link complex facts from across different industries to help you build your case.

At Eisbrouch Marsh, our legal team helps claimants by:

  • Determining where the lawsuit-worthy product flaw lies – the harm may have come in the design, marketing, or some other aspect of the device
  • Being aware of the latest breakthroughs in medical research related to the defective product
  • Working hand-in-hand with experts who can link the injuries, to a reasonable degree of medical certainty, to the defective product
  • Advocating tirelessly on your behalf

Current status of Infuse bone graft litigation

There are nearly 1,000 Infuse bone graft lawsuits currently pending. In May 2014, Medtronic agreed to settle approximately 950 claims, paying out $22 million. According to its SEC filings, Medtronic estimates that law firms intend to file approximately another 2,600 lawsuits over the device.

When a dangerous drug or medical device is the subject of a large number of lawsuits, they are often consolidated in multidistrict litigation (MDL). There has been no MDL ordered for Medtronic claims, so cases are pending across the country. 

Compensation available to plaintiffs

If you have been injured by the Infuse bone graft, you may be entitled to reimbursement for medical treatment. Additional compensation may also be available for pain and suffering and for lost wages. If you lost a loved one due to fatal complications related to the Infuse bone graft, you may be entitled to recover damages through filing a wrongful death claim. Many Infuse bone graft lawsuits are in progress but it is not too late to file suit.

Eisbrouch Marsh attorneys are standing by to offer free, no-obligation case reviews. To learn more about pursuing an Infuse bone graft lawsuit, we invite you to call 201-383-1878.

  1. U.S. Food and Drug Administration, Medical Devices: InFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion Device – P000058, http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm083423.htm
  2. U.S. Food and Drug Administration, Medical Devices: FDA Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion, http://www.fda.gov/MedicalDevices/Safety/alertsandNotices/PublicHealthNotifications/ucm062000.htm
  3. The United States Senate Committee on Finance, Baucus-Grassley Investigation into Medtronic Reveals Manipulated Studies, Close Financial Ties with Researchers, http://www.finance.senate.gov/newsroom/chairman/release/?id=b1d112cb-230f-4c2e-ae55-13550074fe86