Medtronic Infuse Bone Graft Doctor Payments Spark Congressional Probe Over Complications Linked to Unapproved Procedures

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Medtronic Infuse Bone Graft Doctor Payments Spark Congressional Probe Over Complications Linked to Unapproved Procedures

October 2nd, 2008 laurie

Payments to spine doctors have sparked a congressional probe over links to life-threatening complications resulting from unaproved uses for Medtronic’s Infuse Bone Graft.

The Wall Street Journal reports that Senators Herb Kohl and Charles Grassley, in separate letters, have have asked Medtronic for records relating to consulting contracts it has with physicians for its Infuse Bone Graft, used to fuse vertebrae together. These Senators want to know why Medtronic hasn’t publicized the names of spinal doctors paid by the medical device company.

The Wall Street Journal reported last month on complications associated with off-label use of the bone graft, including cases where it has caused dangerous swelling in the neck. Infuse is a manufactured version of a naturally-occurring protein that promotes bone growth. It is approved by the U.S. Food and Drug Administration for use in the lower back, but surgeons say it is used widely off-label in other parts of the spine.

Doctors with financial ties to Medtronic have been among those promoting the off-label use of Infuse. Former employees have alleged the company induced doctors to use Infuse and other spine products by sending them on lavish trips to resorts, paying them undeserved royalties, and handing out lucrative consulting contracts that required little work.

The senators also asked for more information on a 2002 lawsuit filed by former Medtronic legal counsel Ami P. Kelley that has been largely sealed by a federal judge. The suit, which was reviewed by The Wall Street Journal, includes allegations Medtronic paid for doctors’ entertainment at a Memphis strip club.

That lawsuit and a separate one with similar allegations led to a $40 million settlement agreement between Medtronic and the government covering Medtronic products under federal health-insurance programs. The settlement agreement is being challenged in court by former Medtronic travel manager Jacqueline Kay Poteet.

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