- What is the Infuse Bone Graft?
- How is the Infuse Bone Graft used?
- How do I know if my doctor used Infuse in my surgery?
- Did the FDA approve the use of Infuse?
- Is Infuse being implanted in patients in non-FDA approved uses?
- What types of injuries have patients who received Infuse in off-label (non-approved) uses suffered?
- Has Medtronic recalled the Infuse bone graft system?
- Why is Medtronic responsible for injuries patients have suffered from the Infuse device?
- Will I need to sue my surgeon, too, or only Medtronic?
- What types of claims may I be eligible to make against Medtronic?
- What recovery will I receive?
- How quickly must I hire an attorney?
- Will I have to pay a fee for your review of my case?
- How long will a lawsuit take?
- Do I need a lawyer? Why don’t I just contact Medtronic and work it out with their insurance company?
- How do I select an attorney to represent me?
- What is Lieff Cabraser’s track record in Infuse bone graft and defective medical devices cases?
1. What is the Infuse Bone Graft?
The Infuse bone graft system consists of the LT-Cage Device – a small, hollow metal cylinder – which is filled with genetically engineered material, known as rhBMP-2 (recombinant human Bone Morphogenetic Protein-2). This protein stimulates bone growth. The Infuse medical device is manufactured and sold by Medtronic Inc., the nation’s largest manufacturer of medical devices.
2. How is the Infuse Bone Graft used?
The Infuse bone graft device is often used in spinal fusion operations, a procedure in which spinal vertebrae are fused together to reduce back pain. Each year more than 100,000 patients undergoing spinal fusion surgery receive Infuse.
3. How do I know if Infuse was used in my surgery?
All the medical devices used in the surgery should be listed on the op report and also on the “sticker page” related to the op report, and also in the billing records related to the surgery. You can ask the facility for a copy of these records.
4. Did the FDA approve the use of Infuse?
Yes, but only for one type of spine surgery. In 2002, the U.S. Food and Drug Administration approved Infuse for only one very specific type of spinal surgery—an anterior approach lumbar fusion of one level of the spine between the L5 and S1 vertebrae.
5. Is Infuse being implanted in patients in non-FDA approved uses?
Unfortunately, yes. Many patients have undergone spinal fusion surgeries and were implanted with the Infuse bone graft by methods not approved by the FDA, or in parts of their spine for which use of Infuse was never approved by the FDA (off-label use).
Examples of off-label uses include lumbar spine surgeries performed through either a lateral approach (through the side of the body) or a posterior approach (through the back of the body), as well as any use of Infuse in any cervical (neck) spine surgery, regardless of the approach used. Even the anterior approach lumbar fusion can be a non-FDA-approved “off-label” surgery if the LT-Cage is not used.
6. What types of injuries have patients who received Infuse in off-label (non-approved) uses suffered?
Some patients who have had Infuse placed in their spine in non-FDA approved surgeries have experienced ectopic or uncontrolled bone growth at or near the site of the surgery; ongoing or chronic radiating pain in the legs or arms (i.e., neuritis, radiculopathy, or radiculitis); sterility, retrograde ejaculation, or other uro-genital injuries in male patients; nerve injuries causing severe and chronic pain. In cervical spine surgeries some patients experience acute severe neck swelling several days after surgery resulting in death or permanent injury.
7. Has Medtronic recalled the Infuse bone graft system?
No. There has not been any recall of the Infuse bone graft. The only means for patients to receive compensation for their injuries caused by Infuse is by filing a lawsuit against Medtronic.
8. Why is Medtronic responsible for injuries patients have suffered from the Infuse device?
In recent complaints filed by patients, 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. Patients have also charged that Medtronic improperly and illegally promoted and marketed Infuse for non-FDA approved uses, such as the off-label uses described above.
When any drug or medical device, such as Infuse, is used by a physician in an off-label use, the patient must be informed of this off-label or experimental use prior to the surgery, and the risks of such use must be fully disclosed by the manufacturer to both the patient and the physician 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. Many of these patients also were not told of the potential risks of serious and permanent injuries related to an experimental off-label use of this product.
9. Will I need to sue my surgeon, too, or only Medtronic?
We can only answer this question after speaking with you in detail on the facts and circumstances surrounding your Infuse surgery, and regarding what you were told by your surgeon about whether the surgery was “off-label” or “on-label”, and what your surgeon told you (or didn’t tell you) about the risks specific to Infuse. There are complex and very important factors involved in making this decision, and we will consult with you on this issue in detail before deciding whether or not to name your surgeon in a complaint. In certain situations, there may be negligence claims against the surgeon who performed the surgery. In other cases, Medtronic will be the only defendant. To some extent, this analysis will also involve looking into your surgeon’s financial ties to Medtronic, and whether or not any such ties were inappropriate or were undisclosed to you prior to your surgery.
10. What types of claims may I be eligible to make against Medtronic?
The law in most states allows injured patients 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. These 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. 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 claims against Medtronic.
11. What recovery will I receive?
We cannot guarantee or predict any recoveries or outcomes for our clients. Since our law firm is only paid if we win your case (through either settlement or a jury verdict), however, we have every incentive to vigorously and promptly prosecute your claim against Medtronic. Your spouse also might be entitled to an award compensating him or her for loss of household services, marital relations, and/or emotional support.
We regularly work with professional economists who specialize in evaluating economic injuries and losses and in calculating the lump-sum amounts necessary to determine fair monetary compensation for your economic damages. We cannot and will not ever settle your case without your full understanding of the terms and your explicit consent in advance of settlement.
12. How quickly must I hire an attorney?
You should not feel pressured to make an immediate decision about hiring counsel. Focusing on restoring your health should take precedence over legal issues at this difficult time. However, keep in mind that there are certain deadlines in every state for filing lawsuits. These deadlines are known as the statute of limitations and they vary from state to state. Some states have only a one-year statute of limitations.
13. Will I have to pay a fee for your review of my case?
There is no charge for Lieff Cabraser’s review of your case. If we decide we can represent you, we will discuss our contingent fees (calculated as a percentage of the recovery we obtain) and then provide a proposed written contract to be agreed upon with you in writing.
14. How long will a lawsuit take?
We cannot make any guarantee as to when any case will be resolved. In some instances, a case will settle to our client’s satisfaction shortly after it is filed, or perhaps even before it is filed. In other cases, a final resolution may take two years or more. Many cases are settled before trial, but that is no guarantee of any settlement, and some cases do go to trial.
Lieff Cabraser works swiftly and efficiently to obtain the maximum compensation for our clients and to bring each case to a successful conclusion as quickly as possible, while at the same time ensuring that all available legal claims are vigorously pursued. We do not charge our clients hourly fees and we earn no compensation for ourselves until you receive your recovery.
15. Do I need a lawyer? Why don’t I just contact Medtronic and work it out with their insurance company?
It is usually not advisable to try to resolve on your own a complex case involving medical devices causing substantial and prolonged injuries. An attorney can be critical to properly evaluating your case and advising you of your rights. Without counsel, and the expert medical and financial experts an attorney hires, you may never know the true value of your case.
It is important to understand that a company like Medtronic and its insurers employ the services of lawyers who seek to minimize the legal exposure and financial payments that will be made to claimants. In contrast, our duty is to maximize the compensation that our clients are entitled to receive.
16. How do I select an attorney to represent me?
In deciding on representation, you should seek a law firm with substantial experience in successfully prosecuting similar cases. It is important not only to verify the reputation and experience of the law firm as a whole, but to be sure that your case will be handled by lawyers with appropriate experience. You should choose a law firm with sufficient financial resources to conduct a thorough investigation and to prosecute the case through trial and appeal if necessary.
17. What is Lieff Cabraser’s track record in Infuse bone graft and defective medical devices cases?
Lieff Cabraser possesses decades of experience assisting patients in obtaining justice for the injuries they suffered from medical devices and products. We also have specific experience with Infuse cases, and have successfully litigated against Medtronic in other cases involving serious injuries. We represented the family of a patient that received Infuse in surgery on her neck (an off-label use) and subsequently died from complications allegedly caused by Infuse. The matter was ultimately resolved confidentially with all defendants.