Welcome! We regret to inform you that the Injury Board National News Desk has been discontinued. Feel free to browse around and enjoy our previously published articles, or visit The Injury Blog Network for the latest in personal injury news.

Medtronics Whistle-Blower Lawsuit Alleges Conflicts

Posted by Jane Akre
Friday, December 12, 2008 6:38 PM EST
Category: Major Medical, Protecting Your Family
Tags: Medtronic Inc., FDA and Prescription Drugs, Dangerous Products, Medical Devices, Off-Label use

Whistleblower lawsuit against Medtronic for alleged payments to doctors to use the company's bone graft. 

LEARN MORE

 

IMAGE SOURCE:  Medtronic Web Site on Infuse Bone Graft

 

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.  #  


No Comments

Comments for this article are closed.

About the National News Desk

Our mission is to seek the complete truth and provide a full and fair account of the events and issues that surround personal safety, accident prevention, and injury recovery.  We are committed to serving the public with honesty and integrity in these efforts.

Hurt in an accident? Contact an Injury Board member

Subscribe to Blog Updates

Enter your email address if you would like to receive email notifications when comments are made on this post.

Email address

Subscribe

RSS Feed

Add the National News Desk to your favorite RSS reader

Add to Google Reader Add to myYahoo Add to myMSN Add to Bloglines Add to Newsgator Add to Netvibes Add to Pageflakes