Texas Resident Files INFUSE Bone Graft Lawsuit in Federal Court
A Texas woman filed an INFUSE bone graft lawsuit in the U.S. District Court for the Southern District of Texas on May 31, 2013. The plaintiff suffers from long-term and permanent injuries after her physician used the INFUSE bone graft in a manner that was not approved by the FDA during her spinal surgery.
The lawsuit alleges that Medtronic, the manufacturer, was negligent by violating FDA regulations and promoting the INFUSE bone graft for off-label uses. The complaint also states that Medtronic engaged in deceptive marketing practices and misrepresentations that caused the plaintiff’s injuries.
FDA approval of INFUSE bone graft
Bone grafts are used in spinal fusion surgeries that treat medical conditions such as disc degeneration and spinal deformities. During the procedure, the physician usually takes bone from another part of the patient’s body or uses bone donated from another person and inserts it into the space between two vertebrae where the damaged bone was removed. The spinal fusion surgery stimulates the two vertebrae to form one solid bone and eliminates the irritated nerves that caused the back pain. In order to reduce the risk of infection, disease, or bruising that can occur by using donated bone or bone from another part of the patient’s body, Medtronic developed an alternative bone graft that uses synthetic bone proteins.
The INFUSE bone graft is comprised of a hollow metal cylinder that holds two vertebrae in place to direct the stimulation of new bone growth. Synthetic bone proteins are mixed with an absorbable collagen sponge and injected into the spine. On July 2, 2002, Medtronic received FDA clearance to sell INFUSE bone graft for certain spinal fusion surgeries.
INFUSE bone graft lawsuit cites deceptive marketing practices
The FDA only approved the medical device to be used for anterior lumbar interbody fusion procedures. If the device was used for unapproved surgical procedures or off-label applications, it could pose serious safety hazards to patients. On January 10, 2002, the FDA Advisory Committee discussed concerns regarding off-label use of INFUSE bone grafts and the adverse side effects it would pose to patients. An article published in the orthopedic medical journal Spine on May 15, 2006 revealed that unapproved use of the bone graft could result in undesired bone growth in the body and lead to a dangerous inflammatory reaction in patients.
According to the lawsuit, Medtronic misrepresented material information regarding the performance, efficacy, and safety of the INFUSE bone graft to the FDA. Medtronic also allegedly marketed and promoted the medical device for off-label uses even though it was aware that their actions violated FDA regulations and the unapproved use of the device could compromise the health of patients. Medical complications associated with off-label uses of INFUSE bone grafts include unwanted bone growth, inflammation, debilitating pain, and nerve damage.
The court documents state that Medtronic advised their sales representatives to provide doctors with deceptive and fraudulent information regarding off-label uses of the INFUSE bone graft. Medtronic allegedly promoted off-label applications of the medical device to healthcare professionals by providing them with information about other physicians who used the product in ways that were not FDA-approved.The sales representatives requested the doctors speak with consultants who were paid by Medtronic to conduct medical studies and deliver presentations that promoted the benefits of off-label uses for the medical device. According to the complaint, Medtronic purposely concealed the dangers associated with using the INFUSE bone graft for off-label purposes from the public, medical community, and FDA.
Plaintiff suffers Medtronic INFUSE complications
The INFUSE bone graft lawsuit states that the plaintiff underwent a posterior spinal fusion surgery on December 14, 2006. The plaintiff’s physician was allegedly encouraged by Medtronic sales representatives to utilize the INFUSE bone graft for the off-label medical procedure. On June 11, 2009, the plaintiff received a diagnosis of bony overgrowth, nerve damage in the lower back, foraminal stenosis, and other related medical problems.
The plaintiff underwent two additional spinal surgeries in August 2009 in order to treat her extensive injuries. She never fully recovered from the initial INFUSE bone graft surgery and continues to suffer from crippling pain that prevents her from working and performing regular activities. The lawsuit alleges that Medtronic’s deceptive marketing practices and failure to disclose the safety risks of off-label uses for the INFUSE bone graft directly caused plaintiff’s injuries. The plaintiff is seeking compensation her INFUSE bone graft complications and injuries, financial losses, legal fees, and other damages.
- 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
- Medtronic, Medtronic INFUSE Bone Graft https://www.infusebonegraft.com/index-main.html
- The New York Times, Spine Experts Repudiate Medtronic Studies http://www.nytimes.com/2011/06/29/business/29spine.html?pagewanted=all&_r=1&