Personal Injury Law

Medtronic's $800k Consultant

By Jane Akre

Medtronic's Army Doctor

Medical device maker, Medtronic, promises to make transparent its payments to doctors who consult for the company beginning in early 2011. 

In the meantime, news is circulating about the $800,000 that Medtronic paid to Dr. Timothy Kuklo, an army doctor who published a favorably study about the Infuse bone-graft product which later turned out to be fabricated.   

The Journal of Bone and Joint Surgery withdrew the article after the Army accused Kuklo of basing it on "falsified information" and forging the signatures of the co-authors. The article reported that injured soldiers healed better when the Infuse bone graft product was used.  

Medtronic was paying Kuklo his "consulting fees" during the time he shopped the article for publication.  

In an interview with the Wall Street Journal Wednesday, Medtronic says it paid Kuklo for speaking at company events, training doctors, and developing products at a rate of $356,242 a year.  The payments did not go to the study or the published article, Medtronic says.

Doctors are frequently paid consultants and in fact, Medtronic listed 22 consultants working on Infuse to Congress last year. Compensation rates range from $100 to more than $67,000 a year.  Surgeons can earn more. 

Dr. Kuklo has left the Army and is a faculty member at Washington University in St. Louis.

Medtronic has listed Dr. Kuklo's consulting arrangement on "inactive status" but early in 2009, it paid him more than $132,000.  

"Infuse Bone Graft" is a biologically engineered liquid that is used to promote bone growth in spine-repair surgery.

It's become a best seller for Medtronic Inc. of Minneapolis, estimated to have brought in $815 million in the fiscal year that ended April 2008, according to the Wall Street Journal. 

But Infuse Bone Graft has been linked to complications that have occurred during off- label use, specifically in surgery in the neck.

Justice Department Investigation

Medtronic is facing a Justice Department investigation following reports by three whistleblowers who charged the company was illegally marketing Infuse.

In December 2008, two former employees of Medtronic Inc. 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 alleges that the medical device 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, 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.

Medtronic agreed to pay $40 million to settle two of the whistleblower cases, filed in federal district court in Memphis. But the company did not admit any wrongdoing.

Marketing for off-label use is not allowed under the FDA.   #

Full post as published by InjuryBoard on June 18, 2009 (boomark / email).