Frequently Asked Questions
1. What is Medtronic Infuse®?
Infuse® is a bone graft kit manufactured, marketed, and sold by Medtronic, Inc. The Infuse Bone Graft uses the LT-Cage Device which consists of a small hollow metal cylinder. This cylinder is where the genetically engineered material called rhBMP-2 (recombinant human Bone Morphogenetic Protein-2) is placed to stimulate human bone growth.
2. What is the purpose of Medtronic Infuse®?
Medtronic Infuse® is used to fuse vertebrae together by promoting bone growth.
3. What was Medtronic Infuse® originally indicated for?
Infuse® was originally indicated for surgeries that only involved the following:
• Patients suffering from degenerative disk disease;
• Only one disk space between the L1 and S1 vertebrae to be fused; and
• Insertion would occur anteriorly (through the front of the body).
After 2002, Medtronic, Inc. applied for and was approved for two new indications for use of Infuse®. In addition to the original indication (spinal fusion), Infuse® is also now indicated for the treatment of (a) acute, open fractures of the tibial shaft that have been stabilized with IM nail fixation, (b) sinus augmentation (for dental implants), and (c) localized alveolar ridge (roof of mouth) augmentation for defects associated with extraction sockets.
4. How is Medtronic Infuse® supposed to be used pursuant to the approved product label?
The surgeon is to pull the Infuse® product from the vial using the syringe. The surgeon then squirted the Infuse® product from the syringe onto the gauze-like sponge. Once the sponge was fully soaked with the Infuse® product, the surgeon rolled the sponge and inserted it into the cage. The Infuse® soaked sponge-filled cage was then inserted into the disk space to be fused together. The surgeon then secured the cage, usually with a plate and screws. Again, Infuse® was only to be used in this fashion for surgeries involving degenerative disk disease, to fuse only two vertebrae, and to be inserted anteriorly.
5. How is Medtronic Infuse® used outside of the approved product label indications (off-label use)?
Surgeons have used Medtronic Infuse® in various methods outside of what is approved. The following is a list of such off-label uses (note that these items are not mutually exclusive):
• Infuse®-soaked sponge placed into instrument other than cage;
• Infuse® squirted or wiped directly onto the spinal cord;
• Infuse® used to fuse more than two vertebrae;
• Infuse® used to fuse vertebrae outside of the L1-S1 range;
• Infuse® used in fusion surgery to treat ailments other than degenerative disk disease; and/or
• Infuse® used at the wrong dose level.
6. What percentage of surgeries using Medtronic Infuse® are performed “off-label?”
According to recent medical literature, approximately 85%.
7. What are the medical problems with Medtronic Infuse® that warrant litigation?
Medtronic Infuse® was originally thought to be a beneficial alternative to the traditional spinal fusion surgery method of cutting a patient’s hip bone or using a cadaver bone and inserting such bone within the disk space in question. Infuse® was to grow bone within the disk space and thus fuse the affected vertebrae together. Infuse® did promote bone growth, but unfortunately, the product did so too well. Infuse® promotes an excessive amount of bone growth which subsequently impinging on the patient’s spinal cord and the outlying nerves around the cord. The impingement in turn creates a host of injuries to the patient, further detailed below.
8. What injuries can occur from off-label use of Medtronic Infuse®?
Infuse® can cause any of the following damages:
• Ectopic (Abnormal) bone growth (see picture)
• Severe pain
• Severe burning sensation
• Severe numbness and/or tingling
• Cyst formation at site of fusion
• Neck swelling (if Infuse® was used in cervical fusion surgery)
• Respiratory Problems (if Infuse® was used in cervical fusion surgery)
9. What other problems are involved with Medtronic Infuse® that warrant litigation?
Medtronic, Inc. is believed to have paid investigators, who were thought to be independent, to publish case studies and clinical trials without including any of the adverse events that occurred to the patients who were implanted with Infuse®. Clinical trial data that was later submitted to the FDA and then compared to the studies conducted by Medtronic’s paid investigators proved that Medtronic’s investigators failed to supply the FDA with one single adverse event that occurred in the trials.
In addition, Medtronic, Inc. is believed to have promoted the off-label use of Infuse® in behavior that has never before seen in the pharmaceutical/medical device industry. Medtronic allegedly paid orthopedic surgeons millions of dollars to promote the off-label use to their colleagues. In addition, Medtronic, Inc. employed hundreds of personnel to personally assist surgeons across the nation in how to use Infuse® outside of the product’s approved indications.
Finally, Medtronic, Inc. is currently under investigation by the U.S. Senate, the U.S. Department of Justice, and the State of California. In addition, Medtronic, Inc. recently settled a shareholders lawsuit that alleged Medtronic, Inc.’s off-label promotion of Infuse® was directly linked to the drop in Medtronic, Inc.’s stock value.
10. Should patients hold the surgeon responsible for any injuries suffered or
This question can only be answered after we review your claim. It is important for us to review medical documents and discuss with you what was said by your surgeon when you consulted with him/her before your surgery. In some cases the surgeon may be held responsible for negligent actions and in other cases Medtronic will be the only defendant named. You will always have the right to make the decision if a case against your physician should be brought.
11. If I do have a claim against Medtronic, what are the types of claims
available to me?
The claims that are available to you are regulated by certain laws that can be similar in most states. These laws allow for injured parties to claim compensation for past injuries they suffered as a result of a medical device that is defective or unreasonably dangerous or fails to perform as claimed by the manufacturer. Theses damages may include past and future medical expenses, past and future lost earnings and loss of earning capacity, other out-of-pocket expenses, and damages for pain and suffering. In some cases, individuals who can prove that Medtronic recklessly or intentionally deceived them or their physicians regarding the risks of injury from Infuse may also have punitive damages claim against Medtronic.
12. What will be the recovery I would receive?
There is no guarantee that there will be a recovery for your claim, however we will not collect any amount from you if there is no award to you. We can guarantee that we will work zealously and promptly to hold Medtronic responsible for any and all damages that you have suffered from their wrong doing.
13. How does your legal fee work?
We DO NOT get a fee unless you get a recovery. There is no fee for the consultation with our personal injury attorneys. Our fee is based on a percentage of what we obtain for you. All of the expenses associated with your case, from investigation through trial, are advanced by us, and ONLY in the event of a recovery are CLIENT EXPENSES DEDUCTED FROM THE TOTAL RECOVERY. If we are unsuccessful in obtaining a settlement/verdict, you DO NOT pay us any of the advanced expenses. Client expenses are deducted from the total recovery.