Study Finds Medtronic Infuse Bone Graft Frequently Used Off LabelJan 13, 2009 | Parker Waichman LLP, LLP At least 17 percent of procedures using Medtronic's Infuse Bone Graft are off label, according to a new Cleveland Clinic study. This is disturbing, as off-label use of bone graft products like Infuse has been linked to serious complications.
Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body. It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia. It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.
In July, the Food & Drug Administration (FDA) warned that the use of Infuse Bone Graft and similar devices had caused serious problems when they were used off-label in cervical spine (neck) surgeries. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.
For their study, researchers at the Cleveland Clinic saw off-label use of Infuse decrease in Medicare-aged patients but increase for non-Medicare patients, a trend that the investigators said was concerning. “I think these data really emphasize we have to critically study the off-label use of bone biologics,” Isador H. Lieberman, MD, lead author on the study said.
On-label non-Medicare Infuse usage rose to about 127,200 units in 2007 and off-label use increased to about 24,200 in 2007 or 14.3 percent. During the period analyzed, 17.3 percent of all Infuse usage was off-label. The researchers noted an increase in on-label use among the Medicare population from about 9,200 to about 13,000 units, or 7.9 percent of Infuse sales. Off-label use of Infuse also increased in that group, but the percentage of total sales actually went down from 6.5 percent to 2.5 percent.
In September, the Wall Street Journal reported that at least three-quarters of the roughly 200 “adverse events” reported to the FDA involve off-label uses of Infuse Bone Graft. The Journal said that most of these cases involved unwanted bone growths near nerves or in areas outside targeted fusion sites.
Doctors are free to use approved medical devices in anyway they see fit. However, manufacturers are forbidden from promoting any use that has not received FDA approval - known as off-label use
As we’ve previously reported, problems stemming with from off-label use of Infuse have resulted in the filing of several lawsuits against Medtronic. In December, a lawsuit was filed by the family of a woman who received Infuse during neck graft surgery, and later died. That lawsuit claims that a Medtronic sales representative was in the operating room before and during the patient’s surgery, and encouraged her doctor to use Infuse in the off-label procedure.
Last week, we also reported on a Texas woman who a was preparing to file a lawsuit that blames off-label use of Infuse for injuries she suffered after cervical spine surgery. The woman's lawyer said her physician will “provide testimony stating ways in which Medtronic has promoted the off-label use of the product among physicians”.
The Minneapolis Firefighters’ Relief Association also filed a class-action shareholder lawsuit against Medtronic on Dec. 12, alleging that the company did not reveal that most of its revenue came from off-label use of Infuse, did not reveal that off-label use was causing major complications and did not disclose that it adopted an unlawful marketing campaign to promote its use.
Off-label use of Infuse Bone Graft was also the subject of a subpoena filed by the U.S. Department of Justice in November. Medtronic insists that it does not promote off-label use of Infuse, and claims that if doctors were using the bone graft product in off-label procedures, it was because they had determined it was the best therapy for their patients.