Frequently Asked Questions

  1. Can you give me a complete description of the Infuse Bone Graft?
  2. In what ways is the Infuse Bone Graft used?
  3. What was the FDAs role in approving the Infuse Bone Graft?
  4. Is the Infuse Bone Graft being used for non-FDA approved uses?
  5. Can individuals suffer from off-label uses of the Infuse Bone Graft?
  6. Has there been a recall of the Infuse Bone Graft by the FDA or Medtronic?
  7. Should Medtronic be held responsible for the injuries suffered by individuals from the implant of the Infuse Bone Graft?
  8. Should patients hold the surgeon responsible for any injuries suffered or only Medtronic?
  9. If I do have a claim against Medtronic, what are the types of claims available to me?
  10. What will be the recovery I would receive?
  11. When is the best time for me to hire legal counsel?
  12. Are there any fees or cost for you to review my case?
  13. What is the length of time the lawsuit will take to complete?

  1. Can you give me a complete description of the Infuse Bone Graft?

    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. The company that manufactures and sells the device is Medtronic Inc. who is also the largest manufacturer of medical devices.

  2. In what ways is the Infuse Bone Graft used?

    Infuse Bone Graft is used in many ways. The main uses of the system is to create an alternative for bone growth.

  3. Did the FDA approve the Infuse Bone Graft?

    Yes, the Infuse Bone Graft is approved for one type of spinal surgery. In 2002 the FDA approved the use of Infuse Bone Graft for an anterior approach lumbar fusion of one level of the spine between the L5 and S1 vertebrae.

  4. Is the Infuse Bone Graft being used for non-FDA approved uses?

    Yes, the Infuse Bone Graft is and has been used for non-approved uses to harvest bone growth. Examples of the off-label uses include lumbar spine surgeries performed through a lateral approach (through the side of the body) or a posterior approach (through the back of the body).

  5. Can individuals suffer from off-label uses of the Infuse Bone Graft?

    Yes. The types of harm and complications a patient can suffer from the non-approved use of the Infuse Bone Graft include ectopic or uncontrolled bone growth at or near the site of surgery. Other injuries and side effects include ongoing or chronic radiating pain in the legs or arms; sterility, retrograde ejaculation, or other uro-genital injuries in male patients amd nerve injuries causing severe or chronic pain.

  6. Has there been a recall of the Infuse Bone Graft by the FDA or Medtronic?

    No. There has not been a recall of the Infuse Bone Graft. To receive any form of compensation for injuries and pain suffered caused by Infuse is by filing a lawsuit against Medtronic.

  7. Should Medtronic be held responsible for the injuries suffered by individuals from the implant of the Infuse Bone Graft?

    Yes, Medtronic should be held responsible for injuries suffered by individuals who have been implanted with the Infuse Bone Graft for off-label use because of the way Medtronic promoted and marketed the Infuse Bone Graft. It is alleged that Medtronic either negligently or fraudulently misrepresented the risks and benefits of Infuse, including the risk of ectopic or uncontrolled bone growth.

  8. Should patients hold the surgeon responsible for any injuries suffered or only Medtronic?

    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.

  9. 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 are 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.

  10. 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.

  11. When is the best time for me to hire legal counsel?

    You should not feel pressured to make an immediate decision when hiring an attorney. It is imperative that you focus on your well being and that if you choose to take legal action do so with good health. However, there are statute of limitations to file a lawsuit and some states have only a one-year statute of limitations.

  12. Are there any fees or cost for you to review my case?

    There are no fees or costs to review your case. After review of your claim we will notify you if we decide to accept your case. Your case will be based on a contingency which means that there is no cost or fees to you if there is no recovery.

  13. What is the length of time it will take to complete the lawsuit ?

    The time it takes to complete your lawsuit is based on many factors. We cannot guarantee as to when any case will be resolved. In some cases, a case settles shortly after it is filed and in other cases a final resolution may take two years or more. Some cases are settled before trial, but there is no guarantee of any settlement, and some cases do go to trial.


*Trademark Notice
Infuse is a registered trademark of Medtronic Inc. The use of this trademark is for product identification and informational purposes only. Branch Law Firm is in no way affiliated with Medtronic, Inc.