Did Medtronic Promote Dangerous Off-Label Use of Infuse Bone Graft?Sep 4, 2008 | Parker Waichman LLP
Off-label use of Medtronic's Infuse Bone Graft has been linked to serious, life-threatening complications in some patients. According to a new report in The Wall Street Journal, there is some evidence that Medtronic may have promoted the off-label use of the Infuse Bone Graft. Promoting the off-label use of a medical device is illegal, although doctors are allowed to use a device anyway they see fit.
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. According to Medtronic's Website, the Infuse Bone Graft provides a scaffolding where new bone can grow.
In July, the Food & Drug Administration (FDA) warned that the use of the Infuse Bone Graft had caused serious problems when it was used off-label in cervical spine (neck) surgeries. The agency said it received 38 reports over four years of side effects, mainly swelling of neck and throat tissue, which resulted in compression of the airway and other structures in the neck. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.
But according to The Wall Street Journal, the Infuse Bone Graft has injured many patients after it was used in other off-label situations. The Journal said that most these complications cases involve unwanted bone growths near nerves or in areas outside targeted fusion sites. That can lead to pain, repeat surgeries and, in some cases, emergency intervention.
Apparently, off-label use of the Infuse Bone Graft is quite common. According to the Journal, at least three-quarters of the roughly 200 "adverse events" reported to the FDA involve off-label uses of the product.
Medtronic says it doesn't promote off-label use of its medical devices. But doctors paid by Medtronic are free to speak and write about off-label use of Infuse. And according to The Wall street Journal, some of the most influential spine surgeons in the country are paid consulting fees by Medtronic, and some even benefit from sales of the product through royalty deals. These doctors have written positively about off-label use of the Infuse Bone Graft on Websites, in medical journals and at educational meetings.
Infuse was approved in 2002, but before it was, The Wall Street Journal said the FDA had concerns about the product's potential off-label uses. At an advisory committee meeting discussing the product's approval, it asked FDA staff for recommendations on "guarding against off-label use of this product."
According to transcripts of that meeting obtained by the Journal, Dr. Scott Boden, director of the Emory University Orthopaedics & Spine Center who helped present the committee with clinical trial data on behalf of Medtronic, told the panel that discussion about off-label use was "outside the scope of what we ought to be focusing on today." At the time he testified, Dr. Boden was being paid more than $100,000 a year by Medtronic, according to a lawsuit filed last year. Those payments continued at least through 2006, when he received at least $75,000, the Journal reports.
Despite the FDA advisory panel's concerns about unapproved uses of Infuse, by 2003 physicians were already favorably discussing such uses. In May 2003, four surgeons wrote a report for the Website Spine Universe that cited favorable results from using Infuse in the neck area and for fusing larger numbers of vertebrae. The doctors did not provide data related to the cervical-spine results.
The authors included Atlanta surgeon Regis W. Haid Jr. and Emory University surgeon Gerald Rodts. According to The Wall Street Journal, at least three of the four authors had financial relationships with Medtronic, but that was never mentioned in their article. At that time, there were no rules requiring such disclosure.
Medtronic has also been named in three "whistleblower" lawsuits filed by former employees that alleged the company paid doctors to use Infuse Bone Graft and other Medtronic spine products. Medtronic agreed to pay $40 million to settle two of the cases, but admitted no wrongdoing.