Gilman Law LLP, a national law firm representing victims of defective medical devices, is investigating potential claims on behalf of people injured by Medtronic Infuse® bone graft. If you or a loved one have had an Infuse® bone graft and have suffered any of the complications listed below, you may be eligible to file your own Infuse® bone graft lawsuit.
Infuse® Bone Graft Side Effects and Complications
Gilman Law is offering free consultations to victims and their families who have suffered from complications due to the off-label use of a Infuse® Bone Graft, including:
- Excessive swelling of the throat and neck
- Difficulty breaking, swallowing, or speaking
- Heightened risk of retrograde ejaculation, which leads to sterilization
- Compression of the airway
- Respiratory depression
- Nerve damage
Gilman Law LLP is a leading Defective Medical Device Product Liability law firm and is here to help you receive the best compensation for your injuries. If you or a family member have experiencing complications after having an Infuse® bone graft, you may have valuable legal rights. For a free evaluation of your case, please fill out our online form, or CALL TOLL FREE (1-888-252-0048) today.
Medtronic Infuse® Bone Graft Procedure
Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. designed and marketed the Infuse® Bone Graft device (“Infuse®”) for lumbar spine surgery.
Infuse® is a bio-engineered bone filling material containing a bone morphogenetic protein (“BMP”), and is used as an alternative to grafting a patient’s own bone, typically from the patient’s hip. The purpose of Infuse® is to accomplish the same clinical outcomes as grafting a patient’s own bone into these locations but without the difficulties of grafting bone from the hip and other sites, since grafting sites typically have side effects such as pain and long recovery
It uses a genetically engineered protein -rhBMP to help fuse vertebrae in the lower (lumbar) spine in order to treat degenerative disc disease.
Infuse® Bone Graft manufactured by Medtronic, Inc. is only approved for a limited surgical procedure, yet Medtronic allegedly illegally promoted it for a number of off-label procedures according to current pending lawsuits.
Medtronic Allegedly Promoted the Infuse® for Off-Label Use
Infuse® was approved by the Food and Drug Administration (“FDA”) on July 2, 2002, for use only in the lower region of the spine (at levels L4 through S1) to treat degenerative disc disease, and was approved only for anterior surgeries at L4 through S1. That meant that it was initially approved only to be used by surgeons, when the surgeons placed the cage within the vertebrae in the lumbar region of the back, and only by entrance through the abdomen.
On March 9, 2007, the FDA approved the use of Infuse® for dental use to fill space where bone is needed in order to place dental implants (for example, dental implants with an exposed head used to secure dental devices such as crowns, fixed bridges, or dentures.) In dental surgeries, Infuse® is used to make enough bone in the sinus area to place dental implants in the upper jaw. Infuse® is also used to increase bone in extraction sites prior to implant placement.
In addition to use in lower spine fusion surgeries and dental surgeries, Infuse® has been approved for only one other use, that of repair of tibial fractures that have already been stabilized with IM nail fixation after appropriate wound management.
Infuse® has never been approved by the FDA for use in other parts of the body or for use in any other type of procedure, and any such uses are “off-label” uses. And while physicians may use FDA-approved medical devices in any way they see fit, companies are not permitted to promote off-label uses for their medical devices or to pay doctors inducements or kickbacks to promote the off-label uses or to perform procedures using the devices off-label.
The use of Infuse® for cervical spine fusion surgery has never been approved by the FDA, and the use of this product in the cervical spine is an off-label use.
Medtronic Infuse® Bone Graft Lawsuits
Gilman Law is representing victims who have been harmed in off-label uses of Infuse®, which is approved by the FDA only for a small section of the spine in the lower, or lumbar, region. At least 280 reports of adverse events involving Infuse® have been made to the FDA. Approximately 75% of those reports involve off-label use.
On July 1, 2008, the FDA issued a Public Health Notification about complications from the off-label use of Infuse® in the neck, or cervical, area of the spine. The FDA reported that it had received 38 reports over a four year period through July 1, 2008, of complications from cervical uses of Infuse®; and, that some reports were of life-threatening and fatal events. Some of the complications were associated with swelling of the neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck, and patients reported difficulty swallowing, breathing and speaking. Several patients required emergency treatment, including tracheotomies and the insertion of feeding tubes.
The FDA noted that the anatomical proximity of the cervical spine to airway structures in the body has contributed to the seriousness of the events reported and the need for emergency medical intervention with the off-label use of Infuse® in the cervical spine.
The July 1, 2008 FDA safety alert regarding Medtronic’s Infuse product was intended to alert physicians to:
… reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein (rhBMP) when used in the cervical spine. Note that the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use.
FDA Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion, issued July 1, 2008 (emphasis in original).
Medtronic Was Also the Subject of Two Qui Tam Actions
Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. have been named as defendants in two qui tam actions, United States ex rel. (UNDER SEAL) v. Medtronic. Inc., et al., Civil Action No. 02-2709 (W. D. Tenn.), and United States ex rel. Poteet v. Medtronic, Inc., et al., Civil Action No. 03-2979 (W. D. Tenn.) (the “Qui Tam Lawsuits”), both of which allege that Medtronic and MSD violated the False Claims Act, 31 U.S.C. 3729, et seq., by paying illegal kickbacks to certain physicians in connection with promoting the off-label use of Infuse® in the cervical spine, which resulted in the submission of false or fraudulent claims to federal health care programs.
In these lawsuits, the United States Department of Justice contended that between January 1, 1998 and April 30, 2003, MSD made payments and provided other remuneration to a number of physicians and entities in connection with its spinal products in the form of (1) payments and other remuneration for physicians’ attendance and expenses at medical education events, “think tanks”, VIP/opinion leader events, and meetings at resort locations; (2) services and payments for services to physicians through Medtronic’s Healthcare Economic Services and eBusiness Departments; and (3) payments made pursuant to consulting, royalty, fellowship and research agreements with various physicians and entities
Based on its investigation, the United States contended that certain of the payments, services, and remuneration discussed above were improper, resulted in the submission of false or fraudulent claims, and gave rise to certain legal claims.
In July, 2006, Medtronic agreed to pay $40 million to the United States to settle these lawsuits under the False Claims Act, 31 U.S.C. §§ 3729–3733; the Civil Monetary Penalties Law, 42 U.S.C. § 1320a-7a, and the Program Fraud Civil Remedies Act, 31 U.S.C. §§ 3801–3812.
Legal Help for Victims of Defective Medical Devices
Gilman Law LLP is a leading Defective Medical Device Product Liability law firm and is here to help you receive the best compensation for your injuries. If you or a family member have been injured by an off-label use of the Infuse(R) bone graft procedure, you may have valuable legal rights. For a free evaluation of your case, please fill out our online form, or CALL TOLL FREE (1-888-252-0048) today.