Manufactured and sold by Medtronic, Inc., the Infuse Bone Graft has been approved for use in lower spine-repair surgery to promote bone growth. Infuse has been linked to dozens of cases of fatalities or life-threatening complications when used in surgeries on the upper spine and neck.
The national plaintiffs' law firm of Lieff Cabraser Heimann & Bernstein, LLP, represents patients who have suffered severe injuries and had to undergo further surgeries due to the non-approved use of Infuse.
Wrongful Death Lawsuit Filed Against Medtronic for Promoting Off-Label Use of Infuse
On December 2, 2008, the former husband and adult children of Shirley Nisbet filed a wrongful death lawsuit against Medtronic, Inc., in Federal court in Los Angeles. Mrs. Nisbet died August 30, 2008, as a result of post-surgical complications from the off-label use of the Infuse Bone Graft for a cervical spine (neck) surgery.
The complaint charges that Medtronic improperly paid physicians to promote the off-label use of Infuse, and specifically that a Medtronic sales representative was present during Mrs. Nisbet's surgery and encouraged and recommended her physician to use Infuse. Lieff Cabraser is serving as co-counsel for the Nisbet family.
Wide-Spread Off-Label Use of Infuse Bone Graft
Many life-threatening complications are arising from "off label" use of Infuse Bone Graft. Off-label use occurs when a surgeon uses the drug in a way that has not been approved by the U.S. Food and Drug Administration (FDA). According to press reports, spine surgeons say that the artificial bone growth protein is widely marketed off-label to them.
The FDA originally approved Infuse Bone Graft in 2002 for only certain forms of spine surgery because the artificial protein can inflame nearby tissue and can cause bone growth in areas outside the surgical site. Applying Infuse on the neck area, or operating from the back side instead of through an incision in the abdomen to fuse a narrow range of vertebrae in the lower back, is considered off-label use of the drug.
FDA Warnings about Complications from Infuse
In July 2008, the FDA issued a warning to surgeons about reports of life-threatening complications associated with using the Infuse in surgeries on the cervical spine, around the neck. Over a period of four years, the FDA received 38 reports of side effects, mainly swelling of neck and throat tissue, which resulted in compression of the airway and other structures in the neck.
Adverse reactions from use near the neck reported by the FDA include difficulty swallowing, breathing and speaking. Several patients have required emergency treatment, including tracheotomies and the insertion of a feeding tubes, as well as additional surgery.
Other Complications from Off-Label Use
In addition to the 38 cases cited by the FDA, there have been hundreds of other cases in which serious complications have arisen after Infuse was used in other types of off-label situations. According to medical literature and FDA MAUDE reports (website of reports of adverse reactions), many of these instances involve unwanted bone growth near nerves or in areas outside the targeted sites. These adverse reactions have led to painful consequences, including additional surgeries and emergency interventions.
Legal Rights of Injured Infuse Patients
The law in most states provides individuals with legal claims and the right to compensation for injuries they suffer as a result of the negligence of another and the promotion and sale of medical product that causes severe injuries in a use not approved by the FDA.
In personal injury lawsuits against Medtronic for manufacturing an allegedly defective medical device, plaintiffs have typically sought damages for:
- Physical pain and suffering, mental anguish and physical impairment;
- Medical expenses associated with efforts to remedy the injuries as a result of the original surgery; and
- Loss of earnings and/or earning capacity.
In the case of a patient's death, the family of the victim may file a wrongful death action and seek damages.
Contact Medtronic Infuse Personal Injury Attorney | Lawyer
If you or a loved one have been injured by the Medtronic Infuse Bone Graft, please click here to contact an experienced personal injury attorney at the national law firm of Lieff Cabraser. Or you may call us toll-free at 1-800-948-2181 and ask to speak to attorney Heather A. Foster.
We are currently representing families whose loved ones died after use of Infuse.
About Lieff Cabraser
Founded in 1972, Lieff Cabraser Heimann & Bernstein, LLP is an over fifty attorney law firm with offices in San Francisco, New York and Nashville. For the last six years, the National Law Journal has recognized Lieff Cabraser as one of the top plaintiffs' law firms in America.
For our personal injury cases, we bring a team of experienced lawyers. Each client is assigned an individual lawyer. In addition, we have on staff multiple nurses, legal assistants, scientific analysts and case clerks to assist the attorneys. Learn more about our firm.