Senate Finance Committee Questions Manufacturer Medtronic

Senate Finance Committee Questions Medtronic Over Payments to Doctors

Splashed across this morning’s Wall Street Journal was an article that made me sit up and take notice.  Medtronic, the manufacturer of the Infuse bone graft, is being questioned by the Senate Finance Committee.  After pouring through thousands of documents, the Senate Finance Committee released a report concluding Medtronic was "heavily involved in drafting, editing and shaping the content of medical journal articles."  

The problem is these medical journal articles provided the basis for FDA approval, as did doctor speeches to the FDA.  According to the Senate Finance Committee’s report, Medtronic paid $210 million to the doctors who authored these medical journal articles.  Additionally, the doctor who spoke on their behalf admitted to the committee that Medtronic wrote his recommendation, paid him as a consultant for the year, and made him an executive afterwards.

Scientific Challenges to Medtronic Studies Prompted Senate Report

The Senate Finance Committee’s report questions the integrity of the clinical trials, but medical professionals have already questioned the scientific data included in these studies.

In 2011, Eugene Carragee, a professor of orthopedic surgery at Stanford University School of Medicine, published the study that inspired the Senate Finance Committee inquiries.  In his study, published in The Spine Journal, Carragee questioned 13 Medtronic studies in which it appeared the company did not list seriouscomplications associated with Infuse and its sister drug called Amplify, which has yet to gain FDA approval.

Consumers Are Concerned
Given the increased speculation and now two government investigations into Medtronic Infuse, consumers have begun to question whether their injuries were known about previously.  Was Medtronic aware of any side effects of its Infuse product? If you have been injured by your Medtronic Infuse bone graft, you should contact a skilled product liability attorney today.