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Defective Drug and Medical Device Lawyer Peter Brodhead Discusses the Medtronic Infuse Bone Graft Lawsuit
What is the Medtronic Infuse Bone Graft?
The Medtronic Infuse Bone Graft is a bioengineered synthetic bone-growth product that the FDA approved for use primarily in spinal fusion procedures, but it is approved for certain dental procedures as well. It was designed to replace similar medical devices that use an implant made of the patient’s own bone.
According to the New York Times, spinal fusion procedures are performed on an estimated 80,000 patients each year in the U.S. The Infuse Bone Graft system has been used in about half of those procedures.
How does it work?
The Infuse Bone Graft uses a synthetic liquid protein known as recombinant human bone morphogenetic protein, or rhBMP-2, to stimulate bone formation. It performs similarly to a naturally occurring protein found in the body (produced in small amounts) to aid in bone growth and healing. A sponge-like carrier made from bovine Type I collagen is used to release the protein, provide a framework for the bone to grow, and dissipate when the bone has grown.
The FDA restricted its approval of the medical device to the lower region of the spine to treat degenerative disc disease.
When was the Infuse Bone Graft system approved?
The FDA approved the Medtronic Infuse Bone Graft in 2002 for use in lumbar spinal surgeries. Medtronic, however, reportedly marketed its medical device as safe for off-label use. Nearly 85 percent of all procedures using Infuse Bone Graft were off-label, according to the Wall Street Journal.
One common off-label use includes cervical spine fusion procedures. Many of the surgeons who have used the system in off-label procedures are said to inject rhBMP-2 at levels greater than what was approved.
Why is there a Medtronic Infuse Bone Graft lawsuit?
Medtronic allegedly marketed its Infuse Bone Graft system as appropriate for off-label uses, or uses not officially approved by the Food and Drug Administration (FDA). Though doctors are free to use medical devices at their own discretion, medical device manufacturers are not permitted to market their devices for unapproved and off-label uses. Instead, they should seek FDA approval for those other uses.
According to the Spine Journal (pdf), Medtronic concealed side effects shown in clinical studies associated with the Infuse Bone Graft system. These side effects include:
- a significantly high risk of cancer;
- sexual dysfunction;
- respiratory failure; and
On August 3, 2011, the Spine Journal announced that Yale University received a $2.5 million grant to study the risks and benefits of the rhBMP-2 since Medtronic failed to report its findings.
According to the Wall Street Journal, Medtronic allegedly admitted to paying some doctors to use and speak favorably about the Infuse Bone Graft system. Medtronic reportedly paid one surgeon $800,000 over the course of three years for devising a study that reported positive test results and downplayed the risks and complications of the Infuse Bone Graft system. The surgeon allegedly forged the signatures of four Army Medical Center doctors as co-authors of the study and fabricated the group of participants involved in the study.
To speak with one of our Cleveland, Ohio, Medtronic Infuse Bone Graft lawyers, please contact us or call us at (877) 696-3303.
Click here for your free copy of defective drug and medical device attorney Peter Brodhead's book, "Ten Myths and Facts about Defective Drug Injury Claims: What Every Consumer Needs to Know."
What side effects are associated with the Medtronic Infuse Bone Graft?
In 2008, the FDA issued a public health notification concerning the adverse side effects associated with use of the Infuse Bone Graft in cervical spine procedures. The FDA reportedly received 38 complaints reporting serious problems when the system was used during neck surgery. According to the FDA, most of the side effects associated with the system occurred within two to 14 days after surgery. Reported side effects of using the system for off-label uses include:
- Uncontrolled bone growth;
- Male infertility;
- Chronic pain;
- Swelling of the neck and throat;
- Trouble swallowing, breathing and speaking;
- Closed airway;
- Respiratory depression;
- Nerve damage; and
One study, published in the Spine Journal, found that serious complications of the Infuse Bone Graft were seen in 10 to 15 percent of patients in 13 clinical trials over the course of 10 years. Medtronic is accused of never reporting those complications.
Is the Medtronic Infuse Bone Graft System linked to cancer?
Patients treated with high doses of the protein used in the Infuse Bone Graft system allegedly causes a higher risk for cancer than what was reported in previous clinical studies. Those who have been treated in off-label procedures face a greater risk for stomach, thyroid, breast, skin, ovarian, lung, leukemia, prostate, laryngeal, lymphoma, and pancreatic cancers.
Medtronic developed a stronger version of its Infuse Bone Graft system known as Amplify. When Medtronic sought to have Amplify approved, the FDA rejected the application based on data that showed a high cancer risk.
Why is Medtronic being investigated for off-label use?
In 2008, the Justice Department began investigating whether Medtronic marketed its Infuse Bone Graft system for off-label use in cervical spine procedures. The investigation was launched when at least 280 complaints were filed with the FDA alleging serious adverse side effects. One-third of those complaints allegedly involved off-label use of the system. Medtronic announced in 2012 that this investigation has been closed.
According to the Wall Street Journal, in 2011, the Senate Finance Committee launched an investigation of surgeons reportedly paid to withhold information seen during clinical studies regarding complications associated with the bone graft system. Within 10 years, 15 of those surgeons were reportedly paid a total of $62 million for unrelated work.
If you were injured by off-label use of Medtronic's medical device, contact one of our Medtronic Infuse Bone Graft lawyers today for a free consultation, or call us at (877) 696-3303.
To order your free copy of defective drug and medical device lawyer Peter Brodhead's new book, "Ten Myths and Facts about Defective Drug Injury Claims: What Every Consumer Needs to Know," click here or call 216-357-2805.