Two former employees of Medtronic Inc. have filed a whistle-blower suit against the company, alleging lucrative financial relationships between it and seven doctors at the Twin Cities Spine Center, a Minneapolis practice that’s reported to be one of the largest in the country.
The suit, filed this week in U.S. District Court in Boston by two former Medtronic employees, alleges that the medical-device technology company and the doctors signed consulting and royalty agreements for the doctors to use Medtronic’s “Infuse Bone Graft” products in ways not yet approved by the U.S. Food and Drug Administration, the Star Tribune reported.
In one document, the Star Tribune reports a proposed consulting agreement showed Medtronic promised to pay spine doctors $4,000 a day for “services performed.” That arrangement was not to exceed $80,000 a year.
Infuse is a potent substances used in spine-repair surgery. Complications involving “Infuse Bone Graft,” have occurred in off-label use.
In July, the FDA warned doctors that using Infuse in the neck could lead to serious complications.
A California woman died in August after undergoing spinal-fusion surgery that used Infuse. A lawsuit brought by the family of the woman, Shirley Nisbet, alleges that the surgery to her neck used Infuse even though it wasn’t approved by the FDA for such a procedure.
That off-label use is being investigated by the U.S. Department of Justice.
Infuse has become a success for Fridley, MN.- based Medtronic since it was approved for use in the lower back and in some dental applications in 2002, but doctors can use an FDA-approved device any way they see fit.
Medtronic was not aware that Nisbet died until three months later, when the woman’s family filed suit.
38 other adverse health events have been reported to the Food and Drug Administration over Infuse use around the neck, including swelling and difficulty breathing and swallowing.
Medical-device companies are required to report such cases to the FDA, and Medtronic is now moving to make its report to the government, the Journal reported.
Medtronic's Spinal and Biologics unit is located in Memphis, where it employs about 1,300 people, according to the Memphis Business Journal.
One analyst estimates the product has brought sales of about $815 million to Medtronic in the fiscal year that ended in April.
The Infuse Bone Graft is used to fuse or join two vertebrae together to stabilize the spine. #