Two former employees of Medtronic Inc. filed a whistle-blower suit against the company, alleging lucrative financial relationships between it and seven doctors at a Twin Cities spine clinic.
The suit, filed this week in U.S. District Court in Boston, alleged 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. Infuse has become a success for Fridley-based Medtronic since it was approved for use in the lower back and in some dental applications in 2002.
Medtronic has had other recent troubles regarding Infuse, the Wall Street Journal reported Friday. 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. Doctors can use FDA-approved devices in any way they see fit, even if it’s not specifically approved for use on that part of the body, the Journal reported.
Medtronic was not aware that Nisbet died until three months later, when the woman’s family filed suit. 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.
