Medtronic Infuse Bone Graft Lawsuit
We are New York product liability attorneys who believe that you should know all the facts about Medtronic InFuse and related litigation in order to make an informed decision about your next steps.
A review of medical research concerning the InFuse bone graft presents a troubling picture of the many serious medical complications tied to Medtronic’s product and of the company’s misleading marketing efforts. Over 1,000 personal injury cases have been filed against the company already, with more Infuse lawsuits expected in the coming months.
If you have been harmed by the InFuse bone graft, or if a loved one died as a result of off-label use, a Medtronic InFuse bone graft lawyer from the Sanders Firm can meet with you to answer any questions you may have and to help you determine whether you have grounds for bringing a lawsuit against Medtronic. We can help you procure the compensation to which you may entitled and will change no fees unless you receive a jury award or settlement.
Complications linked to InFuse bone grafts
A bone graft is a surgical procedure in which part of a broken or defective bone is replaced by another bone fragment (human or animal). Medtronic produced InFuse, a bioengineered bone growth protein that was designed to replace a traditional bone graft, primarily for use during an anterior lumbar fusion, which treats severe back pain.
Although early research published starting in 2003 suggested that InFuse was both superior to and less risky than traditional bone grafts, mounting complaints and research suggests otherwise.
Infuse bone grafts have been linked to the following adverse side effects:
- uncontrolled bone growth
- unrelieved radiating pain in legs or arms
- retrograde ejaculation, or other urogenital injuries, resulting in temporary or permanent sterility in men
- difficulty breathing, swallowing or speaking
- compression of the airway
- respiratory depression
- nerve damage
Patients who have experienced Infuse complications and injuries following their surgery should contact The Sanders Firm to discuss whether they are entitled to damages through filing a product liability lawsuit.
Off-label uses of Medtronic InFuse
In 2002, the FDA cleared Medtronic InFuse for use only in certain types of surgery, including fusion of the lumbar spine for those with degenerative disc disease (anterior lumbar fusion), but also healing of tibial shaft fractures and certain oral and maxillofacial procedures. By 2011, InFuse was employed in approximately one quarter of all spinal fusion procedures performed in the United States. These procedures also included “off-label” uses not cleared by the FDA, some of which have been associated with life-altering complications and injuries.
For instance, in 2008, the FDA received reports of life-threatening complications associated with cervical spine procedures and issued a warning that this off-label use of the product could cause swelling of the neck and throat, and resultant compression of the airway or neurological structures in the neck, some of which required emergency medical treatment and/or surgery.
In response, the Department of Justice began a formal investigation in that same year and found in their 2011 report that Medtronic had been illegally promoting InFuse to surgeons for use in such off-label procedures.
Research about InFuse financed by Medtronic, falsely reported
Moreover, a crucial volume of The Spine Journal from 2011, which reviewed the scholarly literature and studies associated with the Medtronic InFuse bone graft, found that multiple side effects had been suppressed in such studies, whereas successes had been exaggerated. They also found problematic that early researchers received considerable financial support from Medtronic for their findings.
In response, Medtronic turned over their research for independent review. The 2013 results of the study found that the InFuse bone graft offered no significant improvement over traditional bone grafts, but that it carried real risks.
InFuse bone graft lawsuits filed nationwide
As a result of this new information, many patients now realize that they may have grounds for filing a defective medical device lawsuit against Medtronic. More than 1,000 cases have been filed against the company to date, despite Medtronic’s attempt to have them dismissed on the grounds that the product was cleared by the FDA and that they are not liable for any adverse effects that the product may have had.
However, since the FDA did not approve InFuse for the off-label uses which the company promoted, and since it misrepresented research that it also financed, those who suffered injuries from unapproved uses may have the right to demand compensation from Medtronic.
Plaintiffs are generally seeking monetary damages for medical bills, lost wages and diminished earning potential, as well as pain and suffering. In cases where a loved one lost his or her life do to the product, a wrongful death claim may be brought.
Contact New York product liability attorneys
If you reside in New York City or Long Island and have suffered severe side effects due to the improper utilization or promotion of a Medtronic InFuse bone graft, The Sanders Firm can file a lawsuit on your behalf to secure the compensation that you deserve. Our attorneys have extensive experience in handling product liability claims and have recovered millions of dollars for our clients over the past 46 years.
Contact The Sanders Firm at 1.800 FAIR PLAY (800-324-7752) for a free consultation with one of our New York product liability lawyers to determine whether filing a Medtronic Infuse bone graft lawsuit is the right course of action for you. We believe that no one should suffer because of a company’s questionable behavior in marketing their products.
- NY Times, Outside Review of Clinical Data Finds a Spinal Treatment’s Benefit Overstated http://www.nytimes.com/2013/06/18/business/infuse-a-spinal-treatment-found-no-better-than-older-remedy.html?pagewanted=all&action=click&module=Search®ion=searchResults%230&version=&url=http%3A%2F%2Fquery.nytimes.com%2Fsearch%2Fsitesearch%2F%3Fvertical%3Dbusiness%2F%23%2Fmedtronic%2Binfuse%2Fsince1851%2Fallresults%2F1%2Fallauthors%2Fnewest%2Fbusiness%2F
- Huffington Post, Medtronics Manipulates Safety Data -- When a Fine Should Become a Crime http://www.huffingtonpost.com/spencer-aronfeld/medtronics-fda_b_3412359.html
- Bloomberg, Medtronic’s Infuse No Better Than Bone Graft With Risk http://www.bloomberg.com/news/2013-06-17/medtronic-s-infuse-benefits-equal-bone-graft-with-risk.html
- The Spine Journal, A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lesson learned http://www.spine.org/Documents/TSJJune2011_Carragee_etal_CriticalRev.pdf
- FDA, 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