Infuse Bone Graft Problems Result in DOJ Subpoena for MedtronicNov 18, 2008 | Parker Waichman LLP
Off-label use of Medtronic Inc.'s Infuse Bone Graft product is the subject of a subpoena filed by the U.S. Department of Justice, the company recently revealed. Complications related to off-label use of the Infuse Bone Graft and similar products prompted the Food & Drug Administration (FDA) to issue a health alert earlier this year.
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 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.
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 Craft. The Journal said that most of these complications cases involve unwanted bone growths near nerves or in areas outside targeted fusion sites.
The Wall Street Journal also reported that doctors paid consulting fees by Medtronic have promoted off-label use of Infuse by, among other things, authoring articles that present unapproved uses in a favorable light. Such revelations have already sparked a Congressional investigation into the possible promotion of off-label use of Infuse by Medtronic. While doctors are free to use an FDA approved medical device in any way they see fit, device makers are forbidden from actively promoting or marketing a product based on off-label use.
According to the Dow Jones Newswire, Medtronic revealed the Justice Department's Infuse subpoena during a conference call with investors this morning. Medtronic chief executive Bill Hawkins said during the call that the company is complying with the Justice Department's request, but insisted that Medtronic was not promoting off-label use of Infuse. Hawkins said 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."
During the same call, Hawkins revealed that Medtronic has also seen slowing sales of its spinal products, Dow Jones reported. Hawkins attributed the slowdown to the FDA's July warning about Infuse and off-label procedures.